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

Chiesi Farmaceutici S.p.A.281 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

281

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GlycopyrrolateDRUG

comparison of different dosages of drug

GlycopyrrolateDRUG

comparison of different dosages of drug

GlycopyrrolateDRUG

comparison of different dosages of drug

Comparator

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value) * Patients under Double * Patients under triple therapy (for 1 Mo prior Screening) Exclusion Criteria: * Pregnant or lactating women * Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization * concommitant diseases impacting feasibility or safety

Locations (1)

Medicines Evaluation Unit Ltd.

Manchester, United Kingdom

Outcomes

Primary Outcomes

Aera under curve FEV1 AUC 0-12h

Time frame: day 1 and 7 of treatment period

Data from ClinicalTrials.gov

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