Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT02172352

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31

Brief Summary

To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ba 679 BR low dose

Group Type: EXPERIMENTAL

Ba 679 BR low dose

Intervention Type: DRUG

Placebo inhalation powder

Group Type: PLACEBO_COMPARATOR

Placebo inhalation powder

Intervention Type: DRUG

Ba 679 BR middle dose

Group Type: EXPERIMENTAL

Ba 679 BR middle dose

Intervention Type: DRUG

Ba 679 BR high dose

Group Type: EXPERIMENTAL

Ba 679 BR high dose

Intervention Type: DRUG

Interventions

Ba 679 BR low dose

Intervention Type: DRUG

Ba 679 BR middle dose

Intervention Type: DRUG

Ba 679 BR high dose

Intervention Type: DRUG

Placebo inhalation powder

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.

2. In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)

3. History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)

4. 40 years of age or older

5. Regardless of sex and the length of disease period

Exclusion Criteria

1. A history of bronchial asthma

2. A history of atopic disease, such as allergic rhinitis

3. Blood eosinophil of 440/µl or more

4. Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone

5. A history of respiratory infection, including virus infection within 1 month before study initiation

6. Tuberculosis, lung cancer or a history of pneumonectomy

7. Glaucoma

8. Under treatment of benign prostatic hypertrophy

9. Hypersensitivity to anticholinergic agents or sympathomimetics

10. Difficulty in expectoration of sputum

11. Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease

12. Use of any β blockers

13. A history of myocardial infarction within the past 1 year

14. A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years

15. A history of drug abuse or alcoholism

16. Treatment of psychotic disease

17. Pregnancy, possible pregnancy or lactation

18. A history of participation in any other clinical studies within the past 6 months

19. Judgment by the investigator that the patient is ineligible for inclusion in the present 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

205.139

Identifier Type: -

Identifier Source: org_study_id