A randomised, double-blind, double dummy, multicentre, parallel-group study comparing the efficacy and safety of the test HFA formulation of ipratropium bromide (Cipla Ltd., India) with the reference HFA formulation of ipratropium bromide (Boehringer Ingelheim, UK) in patients with mild or moderate chronic obstructive pulmonary disease (COPD)

Cipla Ltd0 个研究点目标入组 395 人开始时间: 待定最近更新: 2021年11月24日

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•COPD patients diagnosed according to GOLD criteria. Male or female subjects between 40-75 years of age inclusive. Pre bronchodilator FEV1 ï?³ 50% and <= 80% of predicted value. FEV1/FVC ratio pre-bronchodilator < 70% at screening. Smoking history of ï?³ 10 pack years. Patients must be able to effectively use the pMDI without a spacer . Subject or subjectâ??s legally acceptable representative is willing to sign informed consent document after the subject is provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. COPD patients who require regular treatment with ipratropium bromide and who are treated with ipratropium bromide with or without Î²2-agonist inhalation.

•Subjects with a history of asthma, allergic rhinitis, atopy or those who have a total eosinophil count greater than 600/ÂµL . Acute exacerbation requiring hospitalization or Emergency Department treatment or as judged by the investigator or any change in COPD therapy (other than inhalation of short-acting Î²2-agonists as relief medication), within the last 3 months of the screening visit. Use of systemic corticosteroids within the last 3 months of the screening visit . Subjects suffering from any serious uncontrolled medical conditions or any concomitant pulmonary disease. Clinically relevant respiratory infection requiring antibiotics, as judged by the investigator, within the last 3 months prior to the screening visit. Females who are pregnant or lactating.

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