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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Asthma

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Placebo inhalation capsules

Drug: Tiotropium inhalation capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152984

205.301

Details and patient eligibility

About

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

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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