Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo when administered to patients with stable chronic obstructive pulmonary disease (COPD). - Almirall ACLIFORM-COPD

Almirall0 个研究点目标入组 44 人开始时间: 待定最近更新: 2024年4月29日

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•Adult male and female patients aged >=40.
•Patients with stable moderate to severe COPD (GOLD guidelines): Screening Postbronchodilator
•test FEV1/FVC < 70% and FEV1 >=30 and < 80% of predicted normal value.
•Current or ex*smokers of >=10 pack-years.
•Patients who were never randomised in a study involving aclidinium/formoterol fixed-dosecombination (Almirall project code 40464).
•Patients previously randomised in aclidinium monotherapy trial (Almirall project code 34273) are
•allowed in this study only if time elapsed since the finalisation of the previous trial treatment is at
•least 6 months prior to the Screening Visit.

•Patients with history or current diagnosis of asthma
•Patients with no signs of a COPD exacerbation within 6 weeks prior to the screening visit
•Patients with evidence of clinically significant respiratory and/or cardiovascular conditions or
•laboratory abnormalities.
•Patients who are expected to start a pulmonary rehabilitation program during the trial, or
•those who finished or started it within 3 months prior to the Screening Visit.
•Patients with contraindication to anticholinergic drugs such as bladder neck obstruction, acute
•urinary retention, symptomatic non-stable prostatic hypertrophy or (known) narrow-angle

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