Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

Official Title
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A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

Conditions
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Pulmonary Disease, Chronic Obstructive, Asthma

Intervention / Treatment
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* Drug: Tiotropium inhalation capsules
* Drug: Placebo inhalation capsules


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of COPD and diagnosis of asthma before the age of 30 Current or ex-smokers with a cigarette smoking history of at least 10 pack-years Treatment with inhaled steroids at least 1 year before study entry FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1 Post bronchodilator FEV1 less than 70% of FVC at visit 1 Exclusion criteria: Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period. Significant diseases other than COPD or asthma Myocardial infarction within the last 6 months Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year Hospitalisation for heart failure (NYHA Class III or IV) within the last year History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis Known active tuberculosis History of thoracotomy with pulmonary resection History of cancer within the last 5 years (excluding treated basal cell carcinoma) Patients requiring oxygen therapy for more than 1 hour per day Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1 Known hypersensitivity to anticholinergic drugs or lactose

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium inhalation capsules|nan|
|Drug: Placebo inhalation capsules|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity (FVC) |  | 12 weeks | 
| Peak expiratory flow rate (PEFR) |  | 12 weeks | 
| Use of rescue medication |  | 12 weeks | 
| AUC0-6hFEV1 |  | after first dose on Day 1 and after 4 weeks of treatment | 
| Change in trough FEV1 (i.e. trough response) from baseline. |  | after 4 and 12 weeks of treatment | 
| Change in peak FEV1 from baseline (=peak response) after first dose |  | after 4 and 12 weeks of treatment | 
| AUC0-6hFVC defined in the same way as for FEV1. |  | Day 1, week 4 | 
| Trough FVC defined in the same way as for FEV1. |  | Day 1, week 4 | 
| Peak FVC defined in the same way as for FEV1 |  | Day 1, week 4 | 
| Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). |  | 12 weeks | 
| Weekly average number of puffs of rescue medication used |  | 12 weeks | 
| Occurrence of adverse events |  | 12 weeks | 
| Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry |  | 12 weeks | 
| Change from baseline in Physical examination |  | 12 weeks |