Status:
COMPLETED
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Asthma
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT00152984
Start Date
December 1 2004
End Date
April 1 2006
Last Update
December 28 2017
Active Locations (68)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Sart Tilman
Angleur, Belgium, 4031
2
A.Z. VUB
Brussels, Belgium, 1090
3
Boehringer Ingelheim Investigational Site
Genk, Belgium, 3600
4
Boehringer Ingelheim Investigational Site
Hasselt, Belgium, 3500