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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Dose Ranging Study of Ba 679 BR Inhalation Powder Following Single Inhalation in COPD Patients - Double-blind, Placebo-controlled, 4 Treatment, 4 Period Crossover Study-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172352
• Other study ID #: 205.139
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: July 1998

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: May 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 ß 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ba 679 BR low dose

• Ba 679 BR middle dose

• Ba 679 BR high dose

• Placebo inhalation powder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1.0 max (maximum forced expiratory volume in one second)		before and up to 24 hours after each study drug administration	No
Secondary	FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)		before and up to 24 hours after each study drug administration	No
Secondary	FEV1.0 time to response		before and up to 24 hours after each study drug administration	No
Secondary	FEV1.0 Tmax (time to FEV1.0 max)		before and up to 24 hours after each study drug administration	No
Secondary	FEV1.0 at measuring time points up to 24 hours after administration of study drug		before and up to 24 hours after each study drug administration	No
Secondary	FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)		before and up to 24 hours after each study drug administration	No
Secondary	FVC max		before and up to 24 hours after each study drug administration	No
Secondary	FVC at measuring time points up to 24 hours after administration of study drug		before and up to 24 hours after each study drug administration	No
Secondary	Occurrence of adverse events		up to 29 days	No
Secondary	Changes in blood pressure		before and up to 24 hours after each study drug administration	No
Secondary	Changes in pulse rate		before and up to 24 hours after each study drug administration	No
Secondary	Changes in transdermal O2 saturation		before and up to 24 hours after each study drug administration	No
Secondary	Abnormal findings in electrocardiogram (ECG)		before and 1.5 and 24 hours after each administration of study drug	No
Secondary	Abnormal changes in laboratory measurements		at 24 hours after last study drug administration	No
Secondary	Urinary excretion rate		before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration	No
Secondary	MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)		before and up to 24 hours after each study drug administration	No
Secondary	MMEF max		before and up to 24 hours after each study drug administration	No
Secondary	MMEF at measuring time points up to 24 hours after administration of study drug		before and up to 24 hours after each study drug administration	No

External Links

•   Link