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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023112-14 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tiotropium 5 mcg | Experimental | once daily delivered via Respimat inhaler |
|
| tiotropium 2.5 mcg | Experimental | once daily delivered via Respimat inhaler |
|
| placebo | Placebo Comparator | once daily delivered via Respimat inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 Response Determined After a Treatment Period of 12 Weeks. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. |
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Inclusion criteria:
All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation -Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
Male or female patients aged 18 years or more at Visit 0 and 75 years or less at Visit 0.
All patients must have
at least a 3 months history of asthma at the time of enrolment into the trial. The initial diagnosis of asthma must have been made before the patient's age of 40;
a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)= 60% predicted and = 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
Patient's diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (within 10 minutes pre and 15-30 minutes after 400 µg salbutamol/albuterol) resulting in a FEV1 increase of = 12% and = 200mL. If this is not achieved the reversibility test may be repeated once within two weeks.
All patients must be symptomatic despite their current maintenance treatment with low doses of inhaled corticosteroids.
All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of = 1.5.
All patients must have been on maintenance treatment with a low, stable dose of inhaled corticosteroids for at least 4 weeks prior to Visit 1.
Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years ((see Appendix 10.3 for calculation).
Patients must be able to use the Respimat® inhaler correctly.
Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter (e-Diary-compliance of at least 80% is required; refer to Section 6.2.1 for instructions).
Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 205.442.54002 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||||
| 205.442.54005 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. | |
| 32180164 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients treated with matching placebo |
| FG001 | Tio R2.5 | Patients treated with tiotropium inhalation solution 2.5 microgram qd |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| tiotropium 2.5 mcg | Drug | To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler |
|
| tiotropium 5 mcg | Drug | To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler |
|
| Baseline and 12 weeks |
| Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | Baseline and 12 weeks |
| FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 12 weeks |
| FVC (AUC0-3h) Response at the End of the 12-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit. | Baseline and 12 weeks |
| Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment | For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5). | 12 weeks |
| Time to First Severe Asthma Exacerbation During the 12-week Treatment. | Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days. | 12 weeks |
| Time to First Asthma Exacerbation During the 12-week Treatment. | An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms. | 12 weeks |
| Use of Rescue Medication During 24h Period | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | Baseline and 12 weeks |
| Use of Rescue Medication During Daytime | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | Baseline and 12 weeks |
| Use of Rescue Medication During Nighttime | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | Baseline and 12 weeks |
| Capital Federal |
| Argentina |
| 205.442.54003 Boehringer Ingelheim Investigational Site | San Juan Bautista | Argentina |
| 205.442.43002 Boehringer Ingelheim Investigational Site | Linz | Austria |
| 205.442.43003 Boehringer Ingelheim Investigational Site | Schlüsslberg | Austria |
| 205.442.43001 Boehringer Ingelheim Investigational Site | Wels | Austria |
| 205.442.38502 Boehringer Ingelheim Investigational Site | Rijeka | Croatia |
| 205.442.38501 Boehringer Ingelheim Investigational Site | Split | Croatia |
| 205.442.38503 Boehringer Ingelheim Investigational Site | Split | Croatia |
| 205.442.38504 Boehringer Ingelheim Investigational Site | Zagreb | Croatia |
| 205.442.37203 Boehringer Ingelheim Investigational Site | Kohtla-Järve | Estonia |
| 205.442.37201 Boehringer Ingelheim Investigational Site | Rakvere | Estonia |
| 205.442.37202 Boehringer Ingelheim Investigational Site | Tartu | Estonia |
| 205.442.50203 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 205.442.50204 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 205.442.50201 Boehringer Ingelheim Investigational Site | Nivel Guatemala | Guatemala |
| 205.442.50202 Boehringer Ingelheim Investigational Site | Nivel Guatemala | Guatemala |
| 205.442.50205 Boehringer Ingelheim Investigational Site | Vila Hermosa I | Guatemala |
| 205.442.36007 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 205.442.36003 Boehringer Ingelheim Investigational Site | Cegléd | Hungary |
| 205.442.36002 Boehringer Ingelheim Investigational Site | Gödöllö | Hungary |
| 205.442.36004 Boehringer Ingelheim Investigational Site | Komárom | Hungary |
| 205.442.36006 Boehringer Ingelheim Investigational Site | Pécs | Hungary |
| 205.442.36001 Boehringer Ingelheim Investigational Site | Szarvas | Hungary |
| 205.442.36005 Boehringer Ingelheim Investigational Site | Százhalombatta | Hungary |
| 205.442.91011 Boehringer Ingelheim Investigational Site | Ahmedabad | India |
| 205.442.91005 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 205.442.91009 Boehringer Ingelheim Investigational Site | Banglore | India |
| 205.442.91002 Boehringer Ingelheim Investigational Site | Coimbatore | India |
| 205.442.91003 Boehringer Ingelheim Investigational Site | Coimbatore | India |
| 205.442.91004 Boehringer Ingelheim Investigational Site | Coimbatore | India |
| 205.442.91008 Boehringer Ingelheim Investigational Site | Hyderabad | India |
| 205.442.91007 Boehringer Ingelheim Investigational Site | Jaipur | India |
| 205.442.91001 Boehringer Ingelheim Investigational Site | Nagpur | India |
| 205.442.91006 Boehringer Ingelheim Investigational Site | Pune | India |
| 205.442.39007 Boehringer Ingelheim Investigational Site | Acquaviva Delle Fonti (BA) | Italy |
| 205.442.39006 Boehringer Ingelheim Investigational Site | Cagliari | Italy |
| 205.442.39003 Boehringer Ingelheim Investigational Site | Chieti | Italy |
| 205.442.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 205.442.37101 Boehringer Ingelheim Investigational Site | Baldone | Latvia |
| 205.442.37103 Boehringer Ingelheim Investigational Site | Daugavpils | Latvia |
| 205.442.37104 Boehringer Ingelheim Investigational Site | Daugavpils | Latvia |
| 205.442.37102 Boehringer Ingelheim Investigational Site | Talsi | Latvia |
| 205.442.48003 Boehringer Ingelheim Investigational Site | Giżycko | Poland |
| 205.442.48002 Boehringer Ingelheim Investigational Site | Gorzów Wielkopolski | Poland |
| 205.442.48005 Boehringer Ingelheim Investigational Site | Krakow | Poland |
| 205.442.48004 Boehringer Ingelheim Investigational Site | Ostrow Wielkopolska | Poland |
| 205.442.48001 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 205.442.42105 Boehringer Ingelheim Investigational Site | Bardejov | Slovakia |
| 205.442.42107 Boehringer Ingelheim Investigational Site | Humenné | Slovakia |
| 205.442.42104 Boehringer Ingelheim Investigational Site | Košice | Slovakia |
| 205.442.42102 Boehringer Ingelheim Investigational Site | Nitra | Slovakia |
| 205.442.42101 Boehringer Ingelheim Investigational Site | Nové Zámky | Slovakia |
| 205.442.42108 Boehringer Ingelheim Investigational Site | Poprad | Slovakia |
| 205.442.42106 Boehringer Ingelheim Investigational Site | Spišská Nová Ves | Slovakia |
| 205.442.42103 Boehringer Ingelheim Investigational Site | Topoľčany | Slovakia |
| 205.442.82006 Boehringer Ingelheim Investigational Site | Cheongju-si | South Korea |
| 205.442.82002 Boehringer Ingelheim Investigational Site | Gangwon-do | South Korea |
| 205.442.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 205.442.82003 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 205.442.82004 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 205.442.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| Derived |
| Halpin DMG, Hamelmann EH, Frith PA, Moroni-Zentgraf PM, van Hecke B, Unseld A, Kerstjens HAM, Szefler SJ. Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis. Pulm Ther. 2020 Jun;6(1):131-140. doi: 10.1007/s41030-020-00113-w. Epub 2020 Mar 16. |
| 31319851 | Derived | Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6. |
| 26563670 | Derived | Paggiaro P, Halpin DM, Buhl R, Engel M, Zubek VB, Blahova Z, Moroni-Zentgraf P, Pizzichini E. The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):104-13.e2. doi: 10.1016/j.jaip.2015.08.017. Epub 2015 Nov 7. |
| FG002 | Tio R5 | Patients treated with tiotropium inhalation solution 5 microgram qd |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients treated with matching placebo |
| BG001 | Tio R2.5 | Patients treated with tiotropium inhalation solution 2.5 microgram qd |
| BG002 | Tio R5 | Patients treated with tiotropium inhalation solution 5 microgram qd |
| BG003 | 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 | Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. | Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication. | Posted | Least Squares Mean | Standard Error | Liter | Baseline and 12 weeks |
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| Secondary | Trough FEV1 Response Determined After a Treatment Period of 12 Weeks. | The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Least Squares Mean | Standard Error | Liter | Baseline and 12 weeks |
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| Secondary | Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period. | Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | All patients from FAS. | Posted | Least Squares Mean | Standard Error | Liter | Baseline and 12 weeks |
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| Secondary | FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Least Squares Mean | Standard Error | Liter | Baseline and 12 weeks |
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| Secondary | FVC (AUC0-3h) Response at the End of the 12-week Treatment Period. | The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit. | All patients from FAS. | Posted | Least Squares Mean | Standard Error | Liter | Baseline and 12 weeks |
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| Secondary | Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment | For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5). | All patients from FAS. | Posted | Number | Number of patients | 12 weeks |
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| Secondary | Time to First Severe Asthma Exacerbation During the 12-week Treatment. | Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days. | All patients from FAS. | Posted | Median | Inter-Quartile Range | Days | 12 weeks |
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| Secondary | Time to First Asthma Exacerbation During the 12-week Treatment. | An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms. | All patients from FAS. | Posted | Median | Inter-Quartile Range | Days | 12 weeks |
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| Secondary | Use of Rescue Medication During 24h Period | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | All patients from FAS. | Posted | Mean | Standard Error | puffs of rescue medication | Baseline and 12 weeks |
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| Secondary | Use of Rescue Medication During Daytime | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | All patients from FAS. | Posted | Mean | Standard Error | puffs of rescue medication | Baseline and 12 weeks |
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| Secondary | Use of Rescue Medication During Nighttime | Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5. The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week. | All patients from FAS. | Posted | Mean | Standard Error | puffs of rescue medication | Baseline and 12 weeks |
|
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Enter description here, if needed | 1 | 155 | 25 | 155 | ||
| EG001 | Tio R2.5 | Enter description here, if needed | 0 | 154 | 30 | 154 | ||
| EG002 | Tio R5 | Enter description here, if needed | 1 | 155 | 21 | 155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Peak expiratory flow rate decreased | Investigations | MedDRA 15.0 |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
| Male |
|
| Mixed Models Analysis | Restricted maximum likelihood (REML)-based repeated measures approach (MMRM). | <0.0001 | Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint. | Mean Difference (Final Values) | 0.159 | Standard Error of the Mean | 0.036 | 95 | 0.088 | 0.230 | Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit. | No | Superiority or Other |
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