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

NCT ID: NCT02172430

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiotropium

Group Type: EXPERIMENTAL

Tiotropium powder inhalation capsules

Intervention Type: DRUG

Powder inhalation via the HandiHaler® once daily

Oxitropium bromide

Group Type: ACTIVE_COMPARATOR

Tersigan®

Intervention Type: DRUG

2 puffs of oxitropium three times daily via MDI

Interventions

Tiotropium powder inhalation capsules

Powder inhalation via the HandiHaler® once daily

Intervention Type: DRUG

Tersigan®

2 puffs of oxitropium three times daily via MDI

Intervention Type: DRUG

Eligibility 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 (<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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

205.227

Identifier Type: -

Identifier Source: org_study_id