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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002522-29 | EudraCT Number | EudraCT |
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This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone high dose | Experimental | fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate |
|
| fluticasone medium & low doses | Experimental | fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium inhalation | Drug |
| ||
| salmeterol xinafoate |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Moderate or Severe On-treatment COPD Exacerbation | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval. | During randomised treatment, up to 488 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Moderate or Severe On-treatment COPD Exacerbations | Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 352.2046.61006 Boehringer Ingelheim Investigational Site | Concord | New South Wales | Australia | |||
| 352.2046.61001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32943047 | Derived | Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1. | |
| 30545350 | Derived | Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Maintenance | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| fluticasone propionate | Drug |
|
| placebo matched for fluticasone propionate | Drug |
|
| During randomised treatment, up to 488 days |
| Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. | During randomised treatment, up to 488 days |
| Time to First Severe On-treatment COPD Exacerbation | Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval. | During randomised treatment, up to 488 days |
| Number of Severe On-treatment COPD Exacerbations | Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate. | During randomised treatment, up to 488 days |
| Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. | Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. | During randomised treatment, up to 488 days |
| Time to First On-treatment COPD Exacerbation | Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval. | During randomised treatment, up to 488 days |
| Number of On-treatment COPD Exacerbations | Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate. | During randomised treatment, up to 488 days |
| Proportion of Patients With at Least One On-treatment COPD Exacerbation | Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage. | During randomised treatment, up to 488 days |
| Severity of On-treatment COPD Exacerbations | Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe) | During randomised treatment, up to 488 days |
| Change in On-treatment Lung Function as Measured by Trough FEV1 | Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 6, 12, 18 and 52 visits |
| Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale | Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health. Scale from 0 to 4:
"No breathlessness" was given a score of -1 Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 18 and 52 visits |
| Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI) | Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 18 and 52 visits |
| Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT) | Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 18 and 52 visits |
| Change in On-treatment BODE Index | Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 18 and 52 visits |
| Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 12, 18 and 52 visits |
| Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 12, 18 and 52 visits |
| Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 12, 18 and 52 visits |
| Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 12, 18 and 52 visits |
| Change in On-treatment FEV1 as Measured by Home Based Spirometry | Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
| Change in On-treatment FVC as Measured by Home Based Spirometry | Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
| Change in On-treatment PEFR as Measured by Home Based Spirometry | Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
| Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 27 and 52 visits |
| Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 27 and 52 visits |
| Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 27 and 52 visits |
| Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 27 and 52 visits |
| Change in On-treatment Physician Global Evaluation | Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Baseline and week 27 and 52 visits |
| Glebe |
| New South Wales |
| Australia |
| 352.2046.61002 Boehringer Ingelheim Investigational Site | Westmead | New South Wales | Australia |
| 352.2046.61004 Boehringer Ingelheim Investigational Site | Daw Park | South Australia | Australia |
| 352.2046.61003 Boehringer Ingelheim Investigational Site | Toorak Gardens | South Australia | Australia |
| 352.2046.61005 Boehringer Ingelheim Investigational Site | Woodville | South Australia | Australia |
| 352.2046.32002 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 352.2046.32016 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 352.2046.32015 Boehringer Ingelheim Investigational Site | Eupen | Belgium |
| 352.2046.32017 Boehringer Ingelheim Investigational Site | Gilly | Belgium |
| 352.2046.32014 Boehringer Ingelheim Investigational Site | Herentals | Belgium |
| 352.2046.32006 Boehringer Ingelheim Investigational Site | Jambes | Belgium |
| 352.2046.32008 Boehringer Ingelheim Investigational Site | Lebbeke | Belgium |
| 352.2046.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 352.2046.32004 Boehringer Ingelheim Investigational Site | Middelheim | Belgium |
| 352.2046.32010 Boehringer Ingelheim Investigational Site | Montigny-le-Tilleul | Belgium |
| 352.2046.32013 Boehringer Ingelheim Investigational Site | Turnhout | Belgium |
| 352.2046.55002 Boehringer Ingelheim Investigational Site | Goiânia | Brazil |
| 352.2046.55005 Boehringer Ingelheim Investigational Site | Goiânia | Brazil |
| 352.2046.55001 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil |
| 352.2046.55006 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil |
| 352.2046.55003 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 352.2046.35905 Boehringer Ingelheim Investigational Site | Burgas | Bulgaria |
| 352.2046.35902 Boehringer Ingelheim Investigational Site | Rousse | Bulgaria |
| 352.2046.35904 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 352.2046.35906 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 352.2046.35907 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 352.2046.35908 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 352.2046.35903 Boehringer Ingelheim Investigational Site | Stara Zagora | Bulgaria |
| 352.2046.35909 Boehringer Ingelheim Investigational Site | Veliko Tarnovo | Bulgaria |
| 352.2046.86002 Boehringer Ingelheim Investigational Site | Beijing | China |
| 352.2046.86003 Boehringer Ingelheim Investigational Site | Beijing | China |
| 352.2046.86006 Boehringer Ingelheim Investigational Site | Beijing | China |
| 352.2046.86008 Boehringer Ingelheim Investigational Site | Chongqing | China |
| 352.2046.86001 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 352.2046.86004 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 352.2046.86005 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 352.2046.86007 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 352.2046.45001 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark |
| 352.2046.45003 Boehringer Ingelheim Investigational Site | København NV | Denmark |
| 352.2046.45002 Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| 352.2046.3317A Boehringer Ingelheim Investigational Site | Brest | France |
| 352.2046.3317B Boehringer Ingelheim Investigational Site | Brest | France |
| 352.2046.3317C Boehringer Ingelheim Investigational Site | Brest | France |
| 352.2046.3320A Boehringer Ingelheim Investigational Site | Castelnau-le-Lez | France |
| 352.2046.3320B Boehringer Ingelheim Investigational Site | Castelnau-le-Lez | France |
| 352.2046.3320C Boehringer Ingelheim Investigational Site | Castelnau-le-Lez | France |
| 352.2046.3335A Boehringer Ingelheim Investigational Site | Clermont-Ferrand | France |
| 352.2046.3314A Boehringer Ingelheim Investigational Site | Forbach | France |
| 352.2046.3301A Boehringer Ingelheim Investigational Site | Marseille | France |
| 352.2046.3333A Boehringer Ingelheim Investigational Site | Marseille | France |
| 352.2046.3326A Boehringer Ingelheim Investigational Site | Montpellier | France |
| 352.2046.3326C Boehringer Ingelheim Investigational Site | Montpellier | France |
| 352.2046.3325A Boehringer Ingelheim Investigational Site | Nantes | France |
| 352.2046.3325C Boehringer Ingelheim Investigational Site | Nantes | France |
| 352.2046.3325D Boehringer Ingelheim Investigational Site | Nantes | France |
| 352.2046.3334A Boehringer Ingelheim Investigational Site | Nantes | France |
| 352.2046.3324A Boehringer Ingelheim Investigational Site | Nîmes | France |
| 352.2046.3332A Boehringer Ingelheim Investigational Site | Nîmes | France |
| 352.2046.3332B Boehringer Ingelheim Investigational Site | Nîmes | France |
| 352.2046.3332C Boehringer Ingelheim Investigational Site | Nîmes | France |
| 352.2046.3331A Boehringer Ingelheim Investigational Site | Perpignan | France |
| 352.2046.3331B Boehringer Ingelheim Investigational Site | Perpignan | France |
| 352.2046.3331C Boehringer Ingelheim Investigational Site | Perpignan | France |
| 352.2046.3329A Boehringer Ingelheim Investigational Site | Saint-Laurent-du-Var | France |
| 352.2046.3329B Boehringer Ingelheim Investigational Site | Saint-Laurent-du-Var | France |
| 352.2046.3302A Boehringer Ingelheim Investigational Site | Saint-Pierre | France |
| 352.2046.3302B Boehringer Ingelheim Investigational Site | Saint-Pierre | France |
| 352.2046.3302C Boehringer Ingelheim Investigational Site | Saint-Pierre | France |
| 352.2046.3302D Boehringer Ingelheim Investigational Site | Saint-Pierre | France |
| 352.2046.3336A Boehringer Ingelheim Investigational Site | Toulouse | France |
| 352.2046.3336B Boehringer Ingelheim Investigational Site | Toulouse | France |
| 352.2046.3336C Boehringer Ingelheim Investigational Site | Toulouse | France |
| 352.2046.3337A Boehringer Ingelheim Investigational Site | Toulouse | France |
| 352.2046.49012 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 352.2046.49020 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 352.2046.49021 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 352.2046.49008 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 352.2046.49003 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 352.2046.49019 Boehringer Ingelheim Investigational Site | Cottbus | Germany |
| 352.2046.49002 Boehringer Ingelheim Investigational Site | Donaustauf | Germany |
| 352.2046.49013 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 352.2046.49025 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 352.2046.49023 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 352.2046.49024 Boehringer Ingelheim Investigational Site | Geesthacht | Germany |
| 352.2046.49022 Boehringer Ingelheim Investigational Site | Gelnhausen | Germany |
| 352.2046.49001 Boehringer Ingelheim Investigational Site | Großhansdorf | Germany |
| 352.2046.49006 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 352.2046.49014 Boehringer Ingelheim Investigational Site | Immenhausen | Germany |
| 352.2046.49016 Boehringer Ingelheim Investigational Site | Kiel | Germany |
| 352.2046.49004 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 352.2046.49005 Boehringer Ingelheim Investigational Site | Marburg | Germany |
| 352.2046.49015 Boehringer Ingelheim Investigational Site | München | Germany |
| 352.2046.30003 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30004 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30005 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30007 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30008 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30011 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30012 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 352.2046.30006 Boehringer Ingelheim Investigational Site | Heraklion | Greece |
| 352.2046.30009 Boehringer Ingelheim Investigational Site | Larissa | Greece |
| 352.2046.30001 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 352.2046.30002 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 352.2046.36003 Boehringer Ingelheim Investigational Site | Cegléd | Hungary |
| 352.2046.36002 Boehringer Ingelheim Investigational Site | Deszk | Hungary |
| 352.2046.36004 Boehringer Ingelheim Investigational Site | Komárom | Hungary |
| 352.2046.36006 Boehringer Ingelheim Investigational Site | Pécs | Hungary |
| 352.2046.36001 Boehringer Ingelheim Investigational Site | Szarvas | Hungary |
| 352.2046.36005 Boehringer Ingelheim Investigational Site | Százhalombatta | Hungary |
| 352.2046.36011 Boehringer Ingelheim Investigational Site | Szigetszentmiklós | Hungary |
| 352.2046.39002 Boehringer Ingelheim Investigational Site | Catania | Italy |
| 352.2046.39007 Boehringer Ingelheim Investigational Site | Cona | Italy |
| 352.2046.39005 Boehringer Ingelheim Investigational Site | Foggia | Italy |
| 352.2046.39003 Boehringer Ingelheim Investigational Site | Modena | Italy |
| 352.2046.39006 Boehringer Ingelheim Investigational Site | Montescano (pv) | Italy |
| 352.2046.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 352.2046.39004 Boehringer Ingelheim Investigational Site | Sesto S. Giovanni (mi) | Italy |
| 352.2046.39008 Boehringer Ingelheim Investigational Site | Tradate (va) | Italy |
| 352.2046.31004 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
| 352.2046.31001 Boehringer Ingelheim Investigational Site | Leeuwarden | Netherlands |
| 352.2046.31003 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands |
| 352.2046.31002 Boehringer Ingelheim Investigational Site | Veldhoven | Netherlands |
| 352.2046.64007 Boehringer Ingelheim Investigational Site | Auckland NZ | New Zealand |
| 352.2046.64003 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 352.2046.64004 Boehringer Ingelheim Investigational Site | Dunedin | New Zealand |
| 352.2046.64006 Boehringer Ingelheim Investigational Site | Hamilton | New Zealand |
| 352.2046.64001 Boehringer Ingelheim Investigational Site | Newtown Wellington NZ | New Zealand |
| 352.2046.64005 Boehringer Ingelheim Investigational Site | Otahuhu New Zealand | New Zealand |
| 352.2046.64002 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand |
| 352.2046.63001 Boehringer Ingelheim Investigational Site | Caloocan | Philippines |
| 352.2046.63009 Boehringer Ingelheim Investigational Site | City of Muntinlupa | Philippines |
| 352.2046.63003 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 352.2046.63004 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 352.2046.63005 Boehringer Ingelheim Investigational Site | Quezon | Philippines |
| 352.2046.63007 Boehringer Ingelheim Investigational Site | Quezon | Philippines |
| 352.2046.63006 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 352.2046.63008 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 352.2046.48006 Boehringer Ingelheim Investigational Site | Bytom | Poland |
| 352.2046.48003 Boehringer Ingelheim Investigational Site | Ostrow Wielkopolska | Poland |
| 352.2046.48001 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 352.2046.48002 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 352.2046.48009 Boehringer Ingelheim Investigational Site | Rzeszów | Poland |
| 352.2046.48011 Boehringer Ingelheim Investigational Site | Tarnowskie Góry | Poland |
| 352.2046.48005 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 352.2046.48007 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| 352.2046.07006 Boehringer Ingelheim Investigational Site | Ivanovo | Russia |
| 352.2046.07008 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 352.2046.07009 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 352.2046.07001 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 352.2046.07002 Boehringer Ingelheim Investigational Site | Samara | Russia |
| 352.2046.07003 Boehringer Ingelheim Investigational Site | Saratov | Russia |
| 352.2046.07004 Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| 352.2046.07005 Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| 352.2046.07011 Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
| 352.2046.27002 Boehringer Ingelheim Investigational Site | Bellville | South Africa |
| 352.2046.27001 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 352.2046.27003 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 352.2046.27006 Boehringer Ingelheim Investigational Site | eManzimtoti | South Africa |
| 352.2046.27007 Boehringer Ingelheim Investigational Site | Pretoria | South Africa |
| 352.2046.27005 Boehringer Ingelheim Investigational Site | Somerset West | South Africa |
| 352.2046.27004 Boehringer Ingelheim Investigational Site | Tygerberg | South Africa |
| 352.2046.34008 Boehringer Ingelheim Investigational Site | Badajoz | Spain |
| 352.2046.34002 Boehringer Ingelheim Investigational Site | Barakaldo (Bilbao) | Spain |
| 352.2046.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 352.2046.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 352.2046.34009 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| 352.2046.34006 Boehringer Ingelheim Investigational Site | Palma de Mallorca | Spain |
| 352.2046.34010 Boehringer Ingelheim Investigational Site | Pozuelo de Alarcón | Spain |
| 352.2046.34013 Boehringer Ingelheim Investigational Site | Salt (Girona) | Spain |
| 352.2046.34011 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 352.2046.88607 Boehringer Ingelheim Investigational Site | Dawan | Taiwan |
| 352.2046.88608 Boehringer Ingelheim Investigational Site | Dawan | Taiwan |
| 352.2046.88606 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 352.2046.88604 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 352.2046.88601 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 352.2046.88603 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 352.2046.2161A Boehringer Ingelheim Investigational Site | Aryanah | Tunisia |
| 352.2046.2162A Boehringer Ingelheim Investigational Site | Aryanah | Tunisia |
| 352.2046.2165A Boehringer Ingelheim Investigational Site | Sfax | Tunisia |
| 352.2046.2164A Boehringer Ingelheim Investigational Site | Sousse | Tunisia |
| 352.2046.2163A Boehringer Ingelheim Investigational Site | Tunis | Tunisia |
| 352.2046.90009 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 352.2046.90019 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 352.2046.90016 Boehringer Ingelheim Investigational Site | Bursa | Turkey (Türkiye) |
| 352.2046.90010 Boehringer Ingelheim Investigational Site | Denizli | Turkey (Türkiye) |
| 352.2046.90003 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90004 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90006 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90008 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90012 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90017 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 352.2046.90011 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| 352.2046.90014 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| 352.2046.90018 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| 352.2046.90005 Boehringer Ingelheim Investigational Site | İzmit | Turkey (Türkiye) |
| 352.2046.90007 Boehringer Ingelheim Investigational Site | Kayseri | Turkey (Türkiye) |
| 352.2046.90001 Boehringer Ingelheim Investigational Site | Mersin | Turkey (Türkiye) |
| 352.2046.90002 Boehringer Ingelheim Investigational Site | Samsun | Turkey (Türkiye) |
| 352.2046.38007 Boehringer Ingelheim Investigational Site | Ivano-Frankivsk | Ukraine |
| 352.2046.38002 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 352.2046.38003 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 352.2046.38004 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 352.2046.38006 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 352.2046.38005 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine |
| 352.2046.38001 Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| 352.2046.44008 Boehringer Ingelheim Investigational Site | Baillieston, Glasgow | United Kingdom |
| 352.2046.44009 Boehringer Ingelheim Investigational Site | Barnsley | United Kingdom |
| 352.2046.44018 Boehringer Ingelheim Investigational Site | Belfast | United Kingdom |
| 352.2046.44010 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom |
| 352.2046.44003 Boehringer Ingelheim Investigational Site | Cambridge | United Kingdom |
| 352.2046.44026 Boehringer Ingelheim Investigational Site | Chertsey | United Kingdom |
| 352.2046.44006 Boehringer Ingelheim Investigational Site | Chesterfield | United Kingdom |
| 352.2046.44012 Boehringer Ingelheim Investigational Site | Cottingham, Hull | United Kingdom |
| 352.2046.44028 Boehringer Ingelheim Investigational Site | Inverness | United Kingdom |
| 352.2046.44016 Boehringer Ingelheim Investigational Site | Isleworth | United Kingdom |
| 352.2046.44002 Boehringer Ingelheim Investigational Site | Liverpool | United Kingdom |
| 352.2046.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 352.2046.44017 Boehringer Ingelheim Investigational Site | Norwich | United Kingdom |
| 352.2046.44021 Boehringer Ingelheim Investigational Site | Sheffield | United Kingdom |
| 352.2046.44019 Boehringer Ingelheim Investigational Site | Sunderland | United Kingdom |
| 352.2046.44025 Boehringer Ingelheim Investigational Site | Windsor | United Kingdom |
| 27066739 | Derived | Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7. |
| 25196117 | Derived | Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8. |
| FG001 |
| Fluticasone Withdrawal |
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period). |
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated Set (TS) which included all patients who were dispensed study medication and were documented to have taken ≥1 dose of randomised treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Maintenance | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period). |
| BG001 | Fluticasone Withdrawal | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Moderate or Severe On-treatment COPD Exacerbation | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval. | Treated set | Posted | Number | 95% Confidence Interval | days | During randomised treatment, up to 488 days |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Moderate or Severe On-treatment COPD Exacerbations | Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate. | Treated Set | Posted | Mean | 95% Confidence Interval | exacerbations per patient-year | During randomised treatment, up to 488 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. | Treated set | Posted | Number | percentage of participants | During randomised treatment, up to 488 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Severe On-treatment COPD Exacerbation | Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval. | Treated set | Posted | Number | 95% Confidence Interval | days | During randomised treatment, up to 488 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Severe On-treatment COPD Exacerbations | Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate. | Treated set | Posted | Mean | 95% Confidence Interval | exacerbations per patient-year | During randomised treatment, up to 488 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. | Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. | Treated set | Posted | Number | percentage of participants | During randomised treatment, up to 488 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First On-treatment COPD Exacerbation | Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval. | Treated set | Posted | Number | 95% Confidence Interval | days | During randomised treatment, up to 488 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of On-treatment COPD Exacerbations | Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate. | Treated set | Posted | Mean | 95% Confidence Interval | exacerbations per patient-year | During randomised treatment, up to 488 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With at Least One On-treatment COPD Exacerbation | Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage. | Treated set | Posted | Number | percentage of participants | During randomised treatment, up to 488 days |
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| Secondary | Severity of On-treatment COPD Exacerbations | Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe) | Treated set | Posted | Number | percentage of participants | During randomised treatment, up to 488 days |
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| Secondary | Change in On-treatment Lung Function as Measured by Trough FEV1 | Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | Litres | Baseline and week 6, 12, 18 and 52 visits |
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| Secondary | Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale | Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health. Scale from 0 to 4:
"No breathlessness" was given a score of -1 Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 18 and 52 visits |
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| Secondary | Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI) | Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | kg/m2 | Baseline and week 18 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT) | Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | meters | Baseline and week 18 and 52 visits |
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| Secondary | Change in On-treatment BODE Index | Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 18 and 52 visits |
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| Secondary | Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set who completed CASA-Q | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12, 18 and 52 visits |
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| Secondary | Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set who completed CASA-Q | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12, 18 and 52 visits |
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| Secondary | Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set who completed CASA-Q | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12, 18 and 52 visits |
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| Secondary | Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain | Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set who completed CASA-Q | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12, 18 and 52 visits |
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| Secondary | Change in On-treatment FEV1 as Measured by Home Based Spirometry | Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | Litres | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
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| Secondary | Change in On-treatment FVC as Measured by Home Based Spirometry | Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | Litres | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment PEFR as Measured by Home Based Spirometry | Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | Litres/sec | Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits |
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| Secondary | Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 27 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 27 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 27 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score | Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 27 and 52 visits |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in On-treatment Physician Global Evaluation | Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. | Treated set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 27 and 52 visits |
|
Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Maintenance | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period). | 292 | 1,243 | 464 | 1,243 | ||
| EG001 | Fluticasone Withdrawal | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period). | 300 | 1,242 | 458 | 1,242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cor pulmonale chronic | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchitis chemical | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Scrotal haematoma | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Urethral injury | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Angiogram | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypergammaglobulinaemia benign monoclonal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Maxillofacial sinus neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Vocal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cerebral arteriosclerosis | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cerebral microangiopathy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Embolic cerebral infarction | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Meningorrhagia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Radiculitis cervical | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Urethral haemorrhage | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bullous lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Laryngeal leukoplakia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Alcohol detoxification | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Angioplasty | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Oxygen supplementation | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | MEDDRA 16.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Arterial occlusive disease | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Subclavian artery stenosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
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Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
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