CTRI/2014/09/005045
Completed
Phase 4
Comparison of bronchodilator responses of single dose of Tiotropium and Formoterol with 4 doses of Ipratopium and Salbutamol administered via dry powder inhaler, over a period of 24 hours, in adult subjects with COPD.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Subjects diagnosed with COPD according to Global Initiative of Obstructive Lung Disease (GOLD) guidelines
- Sponsor
- Cipla Ltd
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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