Overview

Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Oxitropium
Tiotropium Bromide
Criteria
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 ( 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