A randomised, double-blind, double-dummy, multicentre, parallel-group, safety and efficacy study comparing two ipratropium bromide/salbutamol sulphate (20 ï?g/100 ï?g per actuation) formulations delivered by pressurized metered dose inhaler (pMDI) (ipratropium bromide/salbutamol sulphate CFC pMDI vs. ipratropium bromide/salbutamol sulphate HFA pMDI), administered for 12 weeks in adult patients with chronic obstructive pulmonary disease (COPD).

Cipla Ltd0 个研究点目标入组 290 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients with a confirmed diagnosis of COPD according to the Global Initiative for Obstructive Lung Disease criteria who required regular treatment with both ipratropium bromide and salbutamol sulphate and were well controlled on the combination product and did not require additional Î²2-agonists as regular therapy. Study patients could be current smokers or ex-smokers. Eligible patients also demonstrated forced expiratory volume in one second (FEV1) greater than or equal to 50 percent of the predicted value and had an FEV1/FVC ratio prebronchodilator <70%. All patients gave written, informed consent.

•Patients were excluded from the study if they had a history of asthma, allergic rhinitis or atopy. Patients were also excluded if they had received hospital treatment for acute exacerbation or had other evidence of an acute exacerbation of COPD or if they had received systemic corticosteroids within 4 weeks of the screening visit. Other reasons for exclusion included any serious uncontrolled medical condition or clinically relevant condition or findings at screening that might have compromised the safety of the patients or that might have interfered with the study findings. Patient were also excluded if they were allergic to soyabean or peanuts.

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