NCT02680197

Study to Evaluate Efficacy/Safety of 4 Doses of CHF5259 Via Dry Powder Inhaler (DPI) in Patients With COPD

Randomised, Double Blind, Placebo-controlled, Incomplete Block, 3-way Cross-over Study to Evaluate Efficacy and Safety of 4 Doses of Glycopyrronium Bromide (CHF5259) DPI in Moderate to Severe Patients With COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to investigate the efficacy and safety of different doses CHF5259 a long acting muscarinic antagonist in patients with moderate to severe COPD.

Detailed description

Outpatients attending the hospital clinics/study centres will be recruited. Patients with moderate to severe COPD airflow obstruction according to GOLD 2015 criteria. A total of approximately 300 patients will be enrolled. Patients are followed during 3 different treatment periods of 4 weeks separated each by 3 weeks wash-out period. The study lasts approximately 21 weeks for each patient and a total of 11 clinic visits is performed during the study. The primary endpoint is the Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-12h normalised by time on Day 28.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF5259 or Placebo administration	Administration of 2 puffs of treatment in the morning and in the evening during a 4 week period. Each patient will be allocated to 3 out of the 5 possible treatments.

Timeline

• Start date: 2016-02-29
• Primary completion: 2017-02-06
• Completion: 2017-02-06
• First posted: 2016-02-11
• Last updated: 2020-07-31

Locations

30 sites across 4 countries: Czechia, Germany, Hungary, Romania