Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD

Study Overview
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Brief Summary
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The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Official Title
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A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD

Conditions
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COPD

Intervention / Treatment
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* Drug: Tiotropium 18 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 40 years and older with moderate to severe COPD diagnosis Current/former smokers with at least a 10 pack-year history of cigarette smoking Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods Have no excacerbation within last 4 weeks Hava capability of communicate with investigator Accept to adapt the procedures of study protocol Signed and dated informed consent Exclusion Criteria: History of hypersensitivity to anticholinergics Diagnosis of asthma History of alergic rinit and athopy Current or history of lung cancer Known symptomatic prostatic hypertrophy requiring drug therapy Known narrow-angle glaucoma requiring drug therapy Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy Women who are pregnant or lactating or are planning on becoming pregnant during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiotropium 18 mcg dry powder for inhalation<br>Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR | Drug: Tiotropium 18 mcg<br>* tiotropium 18 mcg once a day<br>|
| Active Comparator: SPIRIVA 18 mcg HANDIHALER<br>Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler | Drug: Tiotropium 18 mcg<br>* tiotropium 18 mcg once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) |  | prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose | 
| Percantage (%) change from baseline in FEV1 and FVC |  | prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose | 
| Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose |  | Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose | 
| - Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response |  | Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of bronchodilator effect and maximum effect |  | 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose | 
| Adverse Events |  | predose and up to 24 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FEV1, FVC, AUC 0-24, bronchodilator efficacy, tiotropium