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

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01476813
Collaborator
(none)
281
Enrollment
1
Location
4
Arms
16
Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
281 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glyco 25

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

Drug: Glycopyrrolate
comparison of different dosages of drug
Other Names:
  • Foster+GLyco 25

    		•
    Experimental: Glyco 50

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

    Drug: Glycopyrrolate
    comparison of different dosages of drug
    Other Names:
  • Foster+GLyco 50

    		•
    Experimental: Glyco 100

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

    Drug: Glycopyrrolate
    comparison of different dosages of drug
    Other Names:
  • Foster+GLyco 100

    		•
    Active Comparator: BDP/FF 400/24

    BDP/FF 400/24

    Drug: Comparator
    comparison of different dosages of drug versus comparator
    Other Names:
  • Foster

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Aera under curve FEV1 AUC 0-12h [day 1 and 7 of treatment period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicines Evaluation Unit Ltd. Manchester United Kingdom

    Sponsors and Collaborators

    • Chiesi Farmaceutici S.p.A.

    Investigators

    • Principal Investigator: Dave Singh, MD, Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chiesi Farmaceutici S.p.A.
    ClinicalTrials.gov Identifier:
    NCT01476813
    Other Study ID Numbers:
    • CCD-1106-PR-0066
    First Posted:
    Nov 22, 2011
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Pulmonary Disease, Chronic Obstructive
    Glycopyrrolate

    Study Results

    No Results Posted as of Oct 29, 2021