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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01476813

Enrollment

281

Registered

2011-11-22

Start date

2012-03-31

Completion date

2013-07-31

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief 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)

Interventions

DRUGGlycopyrrolate

comparison of different dosages of drug

DRUGComparator

comparison of different dosages of drug versus comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Aera under curve FEV1 AUC 0-12h	day 1 and 7 of treatment period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026