Asthma, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, South Africa
Outcome results
None listed