Pulmonary Disease, Chronic Obstructive
Conditions
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
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1.0 max (maximum forced expiratory volume in one second) | before and up to 24 hours after each study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| FEV1.0 time to response | before and up to 24 hours after each study drug administration |
| FEV1.0 Tmax (time to FEV1.0 max) | before and up to 24 hours after each study drug administration |
| 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 |
| 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 |
| FVC max | before and up to 24 hours after each study drug administration |
| 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 |
| Occurrence of adverse events | up to 29 days |
| Changes in blood pressure | before and up to 24 hours after each study drug administration |
| 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 |
| Changes in transdermal O2 saturation | before and up to 24 hours after each study drug administration |
| Abnormal findings in electrocardiogram (ECG) | before and 1.5 and 24 hours after each administration of study drug |
| Abnormal changes in laboratory measurements | at 24 hours after last study drug administration |
| 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 |
| 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 |
| MMEF max | before and up to 24 hours after each study drug administration |
| 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 |
| Changes in pulse rate | before and up to 24 hours after each study drug administration |
Outcome results
None listed