Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated
Interventions
DRUGTiotropium powder inhalation capsules
Powder inhalation via the HandiHaler® once daily
DRUGTersigan®
2 puffs of oxitropium three times daily via MDI
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The patients with COPD (chronic bronchitis, emphysema) whose symptoms are stable and who satisfy the following criteria 1. Patients with FEV1.0 of \<=70% of predicted normal and FEV1.0/FVC of \<=70% in the screening test (The FEV1.0 value should also be \<=70% of predicted normal on the starting day of administration (visit 2).) 2. Patients with a smoking history (\<number of cigarettes smoked a day x number of smoking years\> is \>=200.) 3. Male or female patients aged \>=40 years old
Exclusion criteria
1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult 2. Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon 3. Patients with glaucoma 4. Patients with symptomatic prostatic hypertrophy 5. Patients with hypersensitivity to anticholinergic drugs or powder inhalants 6. Patients with serious complication who are judged by the investigator to be inappropriate as the subjects of study 7. Patients demonstrating clinically problematic abnormal laboratory test values (general blood test, biochemical test, urinalysis). Those showing Glutamic Oxaloacetic Transaminase (GOT) and Glutamic PyruvicTransaminase (GPT) twice the upper limit of the normal range, bilirubin 1.25 times or creatinine 1.25 times of the upper limit of normal range are excluded. 8. Patients with a recent history of myocardial infarction or heart failure (i.e. within 3 months before the screening test) 9. Patients with arrhythmia requiring the treatment with drugs 10. Patients for whom the concomitant use of beta-blocker cannot be prohibited. 11. Patients who began treatment with an ACE inhibitor within 1 month before the screening test 12. Patients with tuberculosis (currently active) or with definite sequela of tuberculosis 13. Patients with a recent history of carcinoma (excluding basal cell carcinoma) (i.e. within the past 5 years) 14. Patients with a history of cystic fibrosis and bronchiectasis 15. Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test) 16. Patients who have taken an investigational drug within one month or within period six times of half-lives of that drug (whichever is longer) before the screening test. 17. Women who are pregnant or who may become pregnant, or those breast feeding 18. Other than above, those who are judged by the investigator to be inappropriate as the subjects of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Adverse Events | up to 52 weeks |
| Changes from baseline in Blood Pressure / Heart Rate | up to 52 weeks |
| Changes from baseline in ECG | up to 52 weeks |
| Changes from baseline in laboratory tests | up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep) | up to 52 weeks |
| Frequency of rescue use of β2 stimulants | up to 2 weeks |
| Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response | week 24 and 52 |
| Patient's impression | week 24 and 52 |
| Physician's global evaluation | week 24 and 52 |
| Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible) | week 24 and 52 |
| Changes from baseline in FEV1.0 at 1 hr post-dosing | week 24 and 52 |
| Changes from baseline in Trough Forced vital capacity (FVC) response | week 24 and 52 |
| Changes from baseline in FVC at 1 hr post-dosing | week 24 and 52 |
Outcome results
None listed