Clinical trial NCT02172352: Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients
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-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: FEV1.0 max (maximum forced expiratory volume in one second)
timeFrame: before and up to 24 hours after each study drug administration
Secondary outcomes:
measure: FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)
timeFrame: before and up to 24 hours after each study drug administration
measure: FEV1.0 time to response
timeFrame: before and up to 24 hours after each study drug administration
measure: FEV1.0 Tmax (time to FEV1.0 max)
timeFrame: before and up to 24 hours after each study drug administration
measure: FEV1.0 at measuring time points up to 24 hours after administration of study drug
timeFrame: before and up to 24 hours after each study drug administration
measure: FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)
timeFrame: before and up to 24 hours after each study drug administration
measure: FVC max
timeFrame: before and up to 24 hours after each study drug administration
measure: FVC at measuring time points up to 24 hours after administration of study drug
timeFrame: before and up to 24 hours after each study drug administration
measure: Occurrence of adverse events
timeFrame: up to 29 days
measure: Changes in blood pressure
timeFrame: before and up to 24 hours after each study drug administration
measure: Changes in pulse rate
timeFrame: before and up to 24 hours after each study drug administration
measure: Changes in transdermal O2 saturation
timeFrame: before and up to 24 hours after each study drug administration
measure: Abnormal findings in electrocardiogram (ECG)
timeFrame: before and 1.5 and 24 hours after each administration of study drug
measure: Abnormal changes in laboratory measurements
timeFrame: at 24 hours after last study drug administration
measure: Urinary excretion rate
timeFrame: 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
measure: MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)
timeFrame: before and up to 24 hours after each study drug administration
measure: MMEF max
timeFrame: before and up to 24 hours after each study drug administration
measure: MMEF at measuring time points up to 24 hours after administration of study drug
timeFrame: before and up to 24 hours after each study drug administration
Other outcomes:
Locations:
Study officials:
References: