NCT01476813

Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Detailed description

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Glycopyrrolate	comparison of different dosages of drug
DRUG	Glycopyrrolate	comparison of different dosages of drug
DRUG	Glycopyrrolate	comparison of different dosages of drug
DRUG	Comparator	comparison of different dosages of drug versus comparator

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2013-07-01
• First posted: 2011-11-22
• Last updated: 2021-10-29

Locations

1 site across 1 country: United Kingdom