Summary:
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A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Qualified Participants Must:
• Be male or female subjects aged 40 years of age or older who have signed an Informed Consent Form prior to initiation of any study-related procedure
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Subjects with a diagnosis of COPD (according to GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD Report) at least 12 months before the screening visit
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Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
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A post-bronchodilator FEV1 > 50% and < 80% of the predicted normal value and,a post-bronchodilator FEV1/FVC < 0.7 at screening anda demonstrated reversibility to ipratropium defined as FEV1 > 5% over baseline 30-45 minutes after inhaling 4 puffs of ipratropium
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Subjects under regular COPD therapy for at least 2 months prior to screening with either inhaled LAMA, inhaled ICS/LABA, inhaled ICS + LAMA
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Symptomatic subjects at screening with a CAT score > 10. This criterion must be confirmed at randomization
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Symptomatic subjects with a BDI focal score < 10. This criterion must be confirmed at randomization
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A cooperative attitude and ability to demonstrate correct use of the inhalers and e-diary.
Qualified Participants May Receive:
Paid Compensation, Study related medical care