A study to compare Tiotropium bromide and formoterol combination single dose with Ipratropium bromide and salbutamol combination four doses administered through rotahaler in adult subjects with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Health Condition 1: null- Subjects diagnosed with COPD according to Global Initiative of Obstructive Lung Disease (GOLD) guidelines
- Registration Number
- CTRI/2014/09/005045
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
•COPD diagnosed according to GOLD criteria (Appendix 1)
•Airway reversibility â?? increase of at least of 12% of FEV1 from the baseline 30 minutes post inhaled 40 mcg of Ipratropium bromide and 200 mcg of Salbutamol combination both delivered through a rotahaler.
•FEV1 less than 65%of the predicted normal and FEV1 /FVC < 70%
•Male or female subjects between 40 to 70years of age
•No COPD exacerbation during past one month
•Smoking history > 10 pack years or significant occupational history
•Written informed consent
•Exacerbation as judged by the investigator within 4 week prior to screening
•Unable to discontinue long-acting bronchodilators including theophylline for 24 hours and short acting bronchodilators for 6 hours prior to onset on the study day.
•Radiological or clinical evidence of other pulmonary diseases
•Subjects with the clinical evidence of heart failure or arrhythmias.
•Concurrent diseases likely to affect the study e.g. tuberculosis, bronchogenic carcinoma, pneumonia, ischemic heart disease, liver disease etc.
•Subjects unable to perform lung functions
•Participation in other clinical studies during the month prior to visit 1
•Subject too ill as judged by the investigators to participate.
•Subject with history of asthma or hay fever or blood eosinophil count over 400mm3 will be Excluded
•Pregnant and lactating women
•Subject with known hypersensitivity to anticholinergic drugs, known symptomatic prostatic hypertrophy or narrow angle glaucoma.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under FEV1 response curveTimepoint: Throughout the study period
- Secondary Outcome Measures
Name Time Method Mean difference in maximum FEV1 from the base line, reference â?? test formulation with 95% Confidence Interval (CI).Timepoint: Throughout the study period;Mean difference in maximum FVC from the base line, reference â?? test formulation with 95% CI.Timepoint: Throughout the study period;Safety assessments include adverse events, serious adverse events, abnormal and clinically significant laboratory test results, clinically significant ECG findings, clinically significant vital signs and physical examination.Timepoint: Throughout the study period;Area under FVC response curve, Time of onset of response, Time to maximum response, Duration of response for each treatment group, Trough FEV1 and FVCTimepoint: Throughout the study period