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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019685-87 | EudraCT Number | ||
| U1111-1141-7422 | Registry Identifier | WHO |
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The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.
Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.
The drug tested in this study is called Roflumilast. Roflumilast is being developed to treat people who have chronic obstructive pulmonary disease (COPD). This study investigated the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate, pulmonary function, and major adverse cardiovascular events (MACE) in COPD patients who were concomitantly treated with a fixed combination of long-acting beta-agonists (LABA) and inhaled glucocorticosteroids.
The study was targeted to enroll approximately 1934 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
Trial treatment was taken in the morning by mouth after breakfast with some water.
The trial consisted of the following periods:
This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 64 weeks. Participants made multiple visits to the clinic which included a follow-up visit at week 64.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast | Active Comparator | concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid |
|
| Placebo | Placebo Comparator | concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | 500 µg, once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement. |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational Site | Box Hill | 3128 | Australia | |||
| Nycomed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29797235 | Derived | Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4. | |
| 29763572 | Derived |
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Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) entered a 4 week baseline period during which all patients received placebo then were enrolled equally in 1 of 2 treatment groups, once a day placebo or roflumilast 500 µg.
Participants took part in the study at 203 investigative sites in Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea (Republic of), Netherlands, Poland, Russia, Slovak Republic, South Africa, Spain, Turkey and United Kingdom from 28 May 2011 to 27 May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast 500 µg | Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
once daily |
|
| Baseline and Week 52 |
| Rate of Severe COPD Exacerbations Per Patient Per Year | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | 52 weeks |
| Rate of COPD Exacerbations Per Patient Per Year All Categories | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | 52 weeks |
| Percentage of Participants Experiencing at Least 1 COPD Exacerbation | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | 52 weeks |
| Time to First COPD Exacerbation All Categories | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | 52 Weeks |
| Time to Second Moderate or Severe COPD Exacerbation | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Time to Third Moderate or Severe COPD Exacerbation | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | 52 Weeks |
| Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year | The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)- Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | 52 Weeks |
| Number of Moderate or Severe COPD Exacerbation Days | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation - start date of exacerbation + 1) of all exacerbations within the category. | 52 Weeks |
| Duration of Moderate or Severe COPD Exacerbations Per Participant | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | 52 Weeks |
| Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC) | Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement. | 52 weeks |
| Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%) | Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement. | 52 weeks |
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6) | FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement. | 52 weeks |
| Change From Baseline in Post-Bronchodilator FEV1/FVC | The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement. | 52 weeks |
| Change From Baseline in Use of Rescue Medication From Daily Diary | Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement. | Baseline and Week 52 |
| Change From Baseline in COPD Symptom Score From Daily Diary | Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome). | 52 weeks |
| Percentage of Symptom-Free Days | Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported. | 52 Weeks |
| Percentage of Rescue Medication-Free Days | Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use. | 52 Weeks |
| Change From Baseline in COPD Assessment Test (CAT) Total Score | Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction. | Baseline and Week 52 |
| Percentage of Participants With Improvement in CAT | Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6. | Baseline and Week 52 |
| Time to Mortality Due to Any Reason During the Treatment Period Score | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Time to Mortality Due to COPD Exacerbation During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks |
| Time to Withdrawal During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Time to Withdrawal Due to COPD Exacerbation During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period | Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). | 52 Weeks |
| Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period | Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Percentage of Participant With All-Cause Hospitalisation During the Treatment Period | Percentage of patients with at least one hospital admission due to any cause. | 52 Weeks |
| Time to First Hospitalisation Due to Any Cause During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Time to Trial Withdrawal Due to an Adverse Event | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
| Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | 52 Weeks |
| Change From Baseline in Body Weight | Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF). | Baseline and Week 52 |
| Change From Baseline in Body Mass Index (BMI) | Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF. | Baseline and Week 52 |
| Clayton |
| 3168 |
| Australia |
| Nycomed Investigational Site | Concord | 2139 | Australia |
| Nycomed Investigational site | Daws Park | 5041 | Australia |
| Nycomed Investigational Site | Frankston | 3199 | Australia |
| Nycomed Investigational Site | Heidelberg | 3084 | Australia |
| Nycomed Investigational Site | Parkville | 3050 | Australia |
| Nycomed Investigational Site | Toorak Gardens | 5065 | Australia |
| Nycomed Investigational Site | Feldbach | 8330 | Austria |
| Nycomed Investigational Site | Graz | 8036 | Austria |
| Nycomed Investigational Site | Salzburg | 5020 | Austria |
| Nycomed Investigational Site | Vienna | 1140 | Austria |
| Nycomed Investigational Site | Brussels | 1000 | Belgium |
| Nycomed Investigational Site | Brussels | 1200 | Belgium |
| Nycomed Investigational Site | Halen | 3545 | Belgium |
| Nycomed Investigational Site | Liège | 4000 | Belgium |
| Nycomed Investigational Site | Malmedy | 4960 | Belgium |
| Nycomed Investigational Site | Belo Horizonte | Brazil |
| Nycomed Investigational Site | Botucatu | Brazil |
| Nycomed Investigational Site | Florianópolis | Brazil |
| Nycomed Investigational Site | Goiânia | Brazil |
| Nycomed Investigational Site | Porto Alegre | Brazil |
| Nycomed Investigational Site | Rio de Janeiro | Brazil |
| Nycomed Investigational Site | São Paulo | Brazil |
| Nycomed Investigational Site | Vitória | Brazil |
| Nycomed Investigational Site | Hamilton | L8N 4A6 | Canada |
| Nycomed Investigational Site | Kingston | K7L 2V7 | Canada |
| Nycomed Investigational Site | Lachine | H8S 2E4 | Canada |
| Nycomed Investigational Site | Niagara Falls | L2G 1J4 | Canada |
| Nycomed Investigational Site | Richmond Hill | L4C 2N9 | Canada |
| Nycomed Investigational Site | Toronto | M5T 3A9 | Canada |
| Nycomed Investigational Site | Toronto | M6H 3M2 | Canada |
| Nycomed Investigational Site | Winnepeg | R2K 3S8 | Canada |
| Nycomed Investigational Site | Hellerup | 2900 | Denmark |
| Nycomed Investigational Site | Hillerød | 3400 | Denmark |
| Nycomed Investigational Site | Hvidovre | 2650 | Denmark |
| Nycomed Investigational Site | København NV | 2400 | Denmark |
| Nycomed Investigational Site | Férolles-Attilly | 77150 | France |
| Nycomed Investigational Site | Nîmes | 30900 | France |
| Nycomed Investigational Site | Poitiers | 86021 | France |
| Nycomed Investigational Site | Saint-Laurent-du-Var | 06700 | France |
| Nycomed Investigational Site | Strasbourg | 67091 | France |
| Nycomed Investigational Site | Berlin | 10367 | Germany |
| Nycomed Investigational Site | Berlin | 10969 | Germany |
| Nycomed Investigational Site | Berlin | 12203 | Germany |
| Nycomed Investigational Site | Fürth | 90766 | Germany |
| Nycomed Investigational Site | Großhansdorf | 22927 | Germany |
| Nycomed Investigational Site | Hanover | 30167 | Germany |
| Nycomed Investigational Site | Homburg | 66421 | Germany |
| Nycomed Investigational Site | Koblenz | 56068 | Germany |
| Nycomed Investigational Site | Marburg | 35043 | Germany |
| Nycomed Investigational Site | Rüdersdorf | 15562 | Germany |
| Nycomed Investigational Site | Alexandroupoli | 68100 | Greece |
| Nycomed Investigational Site | Athens | 10676 | Greece |
| Nycomed Investigational Site | Athens | 11527 | Greece |
| Nycomed Investigational Site | Heraklion, Crete | 71110 | Greece |
| Nycomed Investigational Site | Kavala | 65201 | Greece |
| Nycomed Investigational Site | Larissa | 41100 | Greece |
| Nycomed Investigational Site | Marousi | 15126 | Greece |
| Nycomed Investigational Site | Thessaloniki | 57010 | Greece |
| Nycomed Investigational Site | Balassagyarmat | 2660 | Hungary |
| Nycomed Investigational Site | Budapest | 1125 | Hungary |
| Nycomed Investigational Site | Cegléd | 2700 | Hungary |
| Nycomed Investigational Site | Csorna | 9300 | Hungary |
| Nycomed Investigational Site | Deszk | 6772 | Hungary |
| Nycomed Investigational Site | Érd | Hungary |
| Nycomed Investigational Site | Miskolc | 3526 | Hungary |
| Nycomed Investigational Site | Nyíregyháza | 4400 | Hungary |
| Nycomed Investigational Site | Pécs | 7623 | Hungary |
| Nycomed Investigational Site | Siófok | 8600 | Hungary |
| Nycomed Investigational Site | Sopron | 9400 | Hungary |
| Nycomed Investigational Site | Szombathely | 9700 | Hungary |
| Nycomed Investigational Site | Törökbálint | 2045 | Hungary |
| Nycomed Investigational Site | Ashkelon | 78278 | Israel |
| Nycomed Investigational Site | Beersheba | 84101 | Israel |
| Nycomed Investigational Site | Haifa | 31096 | Israel |
| Nycomed Investigational Site | Haifa | 34362 | Israel |
| Nycomed Investigational Site | Holon | 58100 | Israel |
| Nycomed Investigational Site | Jerusalem | 91031 | Israel |
| Nycomed Investigational Site | Jerusalm | 91120 | Israel |
| Nycomed Investigational Site | Kfar Saba | 44281 | Israel |
| Nycomed Investigational Site | Petah Tikva | 49100 | Israel |
| Nycomed Investigational Site | Rehovot | 76100 | Israel |
| Nycomed Investigational Site | Tel Aviv | 64239 | Israel |
| Nycomed Investigational Site | Tel Aviv | 67891 | Israel |
| Nycomed Investigational Site | Tel Litwinsky | 52621 | Israel |
| Nycomed Investigational Site | Ferrara | 44011 | Italy |
| Nycomed Investigational Site | Genova | 16132 | Italy |
| Nycomed Investigational Site | Milan | 20122 | Italy |
| Nycomed Investigational Site | Milan | 20138 | Italy |
| Nycomed Investigational Site | Modena | 41100 | Italy |
| Nycomed Investigational Site | Monza | 20052 | Italy |
| Nycomed Investigational Site | Pordenone | 33170 | Italy |
| Nycomed Investigational Site | Roma | 00133 | Italy |
| Nycomed Investigational Site | 's-Hertogenbosch | 5200 ME | Netherlands |
| Nycomed Investigational Site | Amersfoort | 3800 BM | Netherlands |
| Nycomed Investigational Site | Arnhem | 6815 AD | Netherlands |
| Nycomed Investigational Site | Enschede | 7500 KA | Netherlands |
| Nycomed Investigational Site | Heerlen | 6419 PC | Netherlands |
| Nycomed Investigational Site | Hoorn | 1624 NP | Netherlands |
| Nycomed Investigational Site | Bialystok | 15-540 | Poland |
| Nycomed Investigational Site | Bydgoszcz | 85-681 | Poland |
| Nycomed Investigational Site | Gliwice | Poland |
| Nycomed Investigational Site | Katowice | 40-753 | Poland |
| Nycomed Investigational Site | Lodz | 90-153 | Poland |
| Nycomed Investigational Site | Lodz | 91-849 | Poland |
| Nycomed Investigational Site | Lodz | 94-010 | Poland |
| Nycomed Investigational Site | Lublin | 20-718 | Poland |
| Nycomed Investigational Site | Oleśnica | Poland |
| Nycomed Investigational Site | Ostrów Wielkopolski | 63-400 | Poland |
| Nycomed Investigational Site | Tarnów | 33-100 | Poland |
| Nycomed Investigational Site | Warsaw | Poland |
| Nycomed Investigational Site | Wroclaw | 50-127 | Poland |
| Nycomed Investigational Site | Wroclaw | 53-301 | Poland |
| Nycomed Investigational Site | Zawadzkie | 47-120 | Poland |
| Nycomed Investigational Site | Chelyabinsk | 454021 | Russia |
| Nycomed Investigational Site | Kazan' | 420029 | Russia |
| Nycomed Investigational Site | Kemerovo | 650002 | Russia |
| Nycomed Investigational Site | Moscow | 105077 | Russia |
| Nycomed Investigational Site | Moscow | 117485 | Russia |
| Nycomed Investigational Site | Moscow | 117574 | Russia |
| Nycomed Investigational Site | Moscow | 125206 | Russia |
| Nycomed Investigational Site | Nizhny Novgorod | 603011 | Russia |
| Nycomed Investigational Site | Novosibirsk | 630087 | Russia |
| Nycomed Investigational Site | Novosibirsk | 630091 | Russia |
| Nycomed Investigational Site | Saint Petersburg | 196084 | Russia |
| Nycomed Investigational Site | Saint Petersburg | 197089 | Russia |
| Nycomed Investigational Site | Saint Petersburg | 197706 | Russia |
| Nycomed Investigational Site | Samara | Russia |
| Nycomed Investigational Site | Saratov | 410012 | Russia |
| Nycomed Investigational Site | Smolensk | 214006 | Russia |
| Nycomed Investigational Site | Volgograd | 400001 | Russia |
| Nycomed Investigational Site | Vsevolozhsk | 188640 | Russia |
| Nycomed Investigational Site | Yaroslavl | 150010 | Russia |
| Nycomed Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| Nycomed Investigational Site | Bardejov | 085 01 | Slovakia |
| Nycomed Investigational Site | Bratislava | 821 06 | Slovakia |
| Nycomed Investigational Site | Bratislava | 826 06 | Slovakia |
| Nycomed Investigational Site | Košice | 040 01 | Slovakia |
| Nycomed Investigational Site | Martin | 036 01 | Slovakia |
| Nycomed Investigational Site | Nitra | 950 01 | Slovakia |
| Nycomed Investigational Site | Nové Zámky | 940 34 | Slovakia |
| Nycomed Investigational Site | Spišská Nová Ves | 052 01 | Slovakia |
| Nycomed Investigational Site | Auckland Park, Johannesburg Gauteng | 2006 | South Africa |
| Nycomed Investigational Site | Benoni Gauteng | 1500 | South Africa |
| Nycomed Investigational Site | Bloemfontein Free State | 9300 | South Africa |
| Nycomed Investigational Site | Cape Town Western Cape | 7764 | South Africa |
| Nycomed Investigational Site | Durban Kwazulu-Natal | 4092 | South Africa |
| Nycomed Investigational Site | Johannesburg | 2193 | South Africa |
| Nycomed Investigational Site | Morningside, Johannesburg Gauteng | 2057 | South Africa |
| Nycomed Investigational Site | Thabazimbi Limpopo | 0380 | South Africa |
| Nycomed Investigational Site | Umkomaas Kwazulu-Natal | 4170 | South Africa |
| Nycomed Investigational Site | Witbank Mpumalanga | 1035 | South Africa |
| Nycomed Investigational Site | Anyang | 431-070 | South Korea |
| Nycomed Investigational Site | Cheongju-si | 361-711 | South Korea |
| Nycomed Investigational Site | Daegu | South Korea |
| Nycomed Investigational Site | Seoul | 110-744 | South Korea |
| Nycomed Investigational Site | Seoul | 120-752 | South Korea |
| Nycomed Investigational Site | Seoul | 152-703 | South Korea |
| Nycomed Investigational Site | Wŏnju | 220-701 | South Korea |
| Nycomed Investigational Site | Barcelona | 08022 | Spain |
| Nycomed Investigational Site | Guadalajara | 19002 | Spain |
| Nycomed Investigational Site | Madrid | 28007 | Spain |
| Nycomed Investigational Site | Pozuelo de Alarcón | 28223 | Spain |
| Nycomed Investigational Site | Santander | 39008 | Spain |
| Nycomed Investigational Site | Terrassa | 08221 | Spain |
| Nycomed Investigational Site | Valencia | 46015 | Spain |
| Nycomed Investigational Site | Ankara | 06590 | Turkey (Türkiye) |
| Nycomed Investigational Site | Çanakkale | 17020 | Turkey (Türkiye) |
| Nycomed Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Nycomed Investigational Site | Izmir | 35100 | Turkey (Türkiye) |
| Nycomed Investigational Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Nycomed Investigational Site | Konya | 42075 | Turkey (Türkiye) |
| Nycomed Investigational Site | Mersin | 33079 | Turkey (Türkiye) |
| Nycomed Investigational Site | Edinburgh | EH16 4TJ | United Kingdom |
| Nycomed Investigational Site | Glasgow | United Kingdom |
| Nycomed Investigational Site | Liverpool | L9 7AL | United Kingdom |
| Nycomed Investigational Site | London | E2 9JX | United Kingdom |
| Nycomed Investigational Site | London | NW3 2PF | United Kingdom |
| Nycomed Investigational Site | Norwich | NR4 7UY | United Kingdom |
| Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC. |
| 28679611 | Derived | Rabe KF, Calverley PMA, Martinez FJ, Fabbri LM. Effect of roflumilast in patients with severe COPD and a history of hospitalisation. Eur Respir J. 2017 Jul 5;50(1):1700158. doi: 10.1183/13993003.00158-2017. Print 2017 Jul. No abstract available. |
| 25684586 | Derived | Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13. |
| 22791991 | Derived | Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. doi: 10.2147/COPD.S31100. Epub 2012 Jun 20. |
Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
| Full Analysis Set (FAS) |
|
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) includes all randomised participants who took at least 1 dose of investigational medicinal product (IMP) after randomisation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast 500 µg | Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid. |
| BG001 | Placebo | Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Chronic Obstructive Pulmonary Disease (COPD) Severity | COPD severity was classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline (2009) as: - Very severe COPD: baseline post-bronchodilator FEV1 %predicted < 30% - Severe COPD: baseline post-bronchodilator FEV1 %predicted ≥ 30% to < 50% - Moderate COPD: baseline post-bronchodilator FEV1 %predicted ≥ 50% to < 80% - Mild COPD: baseline post-bronchodilator FEV1 %predicted ≥ 80%. | Number | participants |
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| COPD Disease Characteristics | Number | participants |
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| Global Initiative for Chronic Obstructive Lung Disease (GOLD) Patient Group | Number | participants |
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| Smoking Status | Number | participants |
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| Cigarette Pack Years | Pack Years = (packs smoked per day) * (years as a smoker) | Mean | Standard Deviation | pack years |
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| Pre-bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Number of participants for whom pre-bronchodilator FEV1 data was available was 938 and 937 in each treatment arm, respectively. | Mean | Standard Deviation | Liters |
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| Post-bronchodilator FEV1 | Mean | Standard Deviation | Liters |
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| Pre-bronchodilator FEV1 Predicted | Number of participants for whom pre-bronchodilator FEV1 data was available was 938 and 933 in each treatment arm, respectively. | Mean | Standard Deviation | percent of predicted |
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| Post-bronchodilator FEV1 Predicted | Mean | Standard Deviation | percent predicted |
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| FEV1 Reversibility % Increase | FEV reversibility (%) = (post-bronchodilator FEV minus pre-bronchodilator FEV) / pre-bronchodilator FEV * 100. Number of participants for whom FEV1 reversibility % increase data was available was 912 and 915 in each treatment arm, respectively. | Mean | Standard Deviation | percent reversibility |
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| FEV1 Reversibility Increase | Number of participants for whom FEV1 reversibility increase data was available was 912 and 915 in each treatment arm, respectively. | Mean | Standard Deviation | mL |
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| Post-bronchodilator FEV1/Forced Vital Capacity (FVC) | Calculated as FEV1/FVC * 100 | Mean | Standard Deviation | FEV1/FVC percent |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | 95% Confidence Interval | exacerbations per patient per year | 52 weeks |
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| Secondary | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters | Baseline and Week 52 |
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| Secondary | Rate of Severe COPD Exacerbations Per Patient Per Year | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | 95% Confidence Interval | exacerbations per patient per year | 52 weeks |
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| Secondary | Rate of COPD Exacerbations Per Patient Per Year All Categories | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | 95% Confidence Interval | exacerbations per patient per year | 52 weeks |
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| Secondary | Percentage of Participants Experiencing at Least 1 COPD Exacerbation | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Time to First COPD Exacerbation All Categories | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | 95% Confidence Interval | days | 52 Weeks |
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| Secondary | Time to Second Moderate or Severe COPD Exacerbation | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | 95% Confidence Interval | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Time to Third Moderate or Severe COPD Exacerbation | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks |
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| Secondary | Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year | The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)- Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Number | participants | 52 Weeks |
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| Secondary | Number of Moderate or Severe COPD Exacerbation Days | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation - start date of exacerbation + 1) of all exacerbations within the category. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | Standard Deviation | days | 52 Weeks |
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| Secondary | Duration of Moderate or Severe COPD Exacerbations Per Participant | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations. | Posted | Mean | Standard Deviation | days | 52 Weeks |
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| Secondary | Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC) | Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters | 52 weeks |
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| Secondary | Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%) | Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters/second | 52 weeks |
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| Secondary | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6) | FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Least Squares Mean | Standard Error | liters | 52 weeks |
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| Secondary | Change From Baseline in Post-Bronchodilator FEV1/FVC | The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | Standard Deviation | percent | 52 weeks |
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| Secondary | Change From Baseline in Use of Rescue Medication From Daily Diary | Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis. | Posted | Least Squares Mean | Standard Error | puffs per day | Baseline and Week 52 |
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| Secondary | Change From Baseline in COPD Symptom Score From Daily Diary | Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome). | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | 52 weeks |
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| Secondary | Percentage of Symptom-Free Days | Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | Standard Deviation | percentage of days | 52 Weeks |
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| Secondary | Percentage of Rescue Medication-Free Days | Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | Standard Deviation | percentage of days | 52 Weeks |
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| Secondary | Change From Baseline in COPD Assessment Test (CAT) Total Score | Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and Week 52 |
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| Secondary | Percentage of Participants With Improvement in CAT | Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Number | percentage of participants | Baseline and Week 52 |
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| Secondary | Time to Mortality Due to Any Reason During the Treatment Period Score | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Time to Mortality Due to COPD Exacerbation During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks |
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| Secondary | Time to Withdrawal During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Time to Withdrawal Due to COPD Exacerbation During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period | Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Number | percentage of participants | 52 Weeks |
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| Secondary | Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period | Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | Posted | Median | Full Range | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Percentage of Participant With All-Cause Hospitalisation During the Treatment Period | Percentage of patients with at least one hospital admission due to any cause. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | Posted | Number | percentage of participants | 52 Weeks |
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| Secondary | Time to First Hospitalisation Due to Any Cause During the Treatment Period | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events. | Posted | Median | 95% Confidence Interval | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Time to Trial Withdrawal Due to an Adverse Event | Time to event will be calculated as date of onset of event - date of first intake of double-blind study drug + 1 day. | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events. | Posted | Median | Full Range | days | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) |
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| Secondary | Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | 52 Weeks |
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| Secondary | Change From Baseline in Body Weight | Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF). | Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline and Week 52 |
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| Secondary | Change From Baseline in Body Mass Index (BMI) | Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF. | Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis. | Posted | Least Squares Mean | Standard Error | kg/m^2 | Baseline and Week 52 |
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52 weeks
Safety Population included all randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Roflumilast 500 µg | Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid. | 249 | 968 | 228 | 968 | ||
| EG001 | Placebo | Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid. | 285 | 967 | 114 | 967 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Polycythaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Arrhythmia supraventricular | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrial thrombosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Bundle branch block right | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Coronary artery insufficiency | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Left ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Mitral valve stenosis | 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 |
| |
| Palpitations | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Accessory auricle | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vitello-intestinal duct remnant | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thyrotoxic crisis | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Erysipelas | 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 rotavirus | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Laryngitis | 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 |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Parotid abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia moraxella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | 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 |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Transplant evaluation | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | 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 |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | 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 |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Bladder adenocarcinoma stage unspecified | 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 |
| |
| Bladder neoplasm | 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 cancer metastatic | 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 |
| |
| Eyelid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Laryngeal cancer | 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 melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | 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 |
| |
| Rectal cancer | 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 of lung | 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 |
| |
| Carotid sinus syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Trigeminal nerve disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nephrolithiasis | 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 mass | 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 |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory failure | 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 |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleurisy | 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 hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary mass | 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 |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Perivascular dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alcohol detoxification | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aortic occlusion | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leriche syndrome | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.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 |
|---|---|
| C424423 | Roflumilast |
Not provided
Not provided
Not provided
| > 65 years |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
| Austria |
|
| Belgium |
|
| Brazil |
|
| Canada |
|
| Denmark |
|
| France |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| Israel |
|
| Italy |
|
| Korea, Republic Of |
|
| Netherlands |
|
| Poland |
|
| Russian Federation |
|
| Slovakia |
|
| South Africa |
|
| Spain |
|
| Turkey |
|
| United Kingdom |
|
| Moderate |
|
| Severe |
|
| Very Severe |
|
| Predominantly chronic bronchitis |
|
| Combined emphysema and chronic bronchitis |
|
| Missing |
|
| B: low risk, more symptoms |
|
| C: high risk, less symptoms |
|
| D: high risk, more symptoms |
|
| Missing |
|
| Former smoker |
|
| Nonsmoker |
|
| Participants |
|
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