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

Chiesi

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Glycopyrrolate; Drug: Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476813

CCD-1106-PR-0066

Details and patient eligibility

About

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

Full 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)

Enrollment: 281 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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281 participants in 4 patient groups

Glyco 25

Experimental group

Description:

BDP/FF (400/24 daily)+ Glyco 25µg daily

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Glyco 50

Experimental group

Description:

BDP/FF (400/24 daily)+ Glyco 50 µg daily

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Glyco 100

Experimental group

Description:

BDP/FF (400/24 daily)+ Glyco 100µg daily

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate

BDP/FF 400/24

Active Comparator group

Description:

BDP/FF 400/24

Treatment:

Drug: Comparator