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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo inhalation powder; Drug: Ba 679 BR middle dose; Drug: Ba 679 BR high dose; Drug: Ba 679 BR low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02172352

205.139

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

28 participants in 4 patient groups, including a placebo group

Ba 679 BR low dose

Experimental group

Treatment:

Drug: Ba 679 BR low dose

Placebo inhalation powder

Placebo Comparator group

Treatment:

Drug: Placebo inhalation powder

Ba 679 BR middle dose

Experimental group

Treatment:

Drug: Ba 679 BR middle dose

Ba 679 BR high dose

Experimental group

Treatment:

Drug: Ba 679 BR high dose