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.

Cipla Ltd0 个研究点目标入组 18 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

发起方