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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01476813
First received: November 18, 2011
Last updated: July 26, 2013
Last verified: July 2013

November 18, 2011
July 26, 2013
March 2012
September 2012   (final data collection date for primary outcome measure)
Aera under curve FEV1 AUC 0-12h [ Time Frame: day 1 and 7 of treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476813 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Glycopyrrolate
    comparison of different dosages of drug
    Other Name: Foster+GLyco 25
  • Drug: Glycopyrrolate
    comparison of different dosages of drug
    Other Name: Foster+GLyco 50
  • Drug: Glycopyrrolate
    comparison of different dosages of drug
    Other Name: Foster+GLyco 100
  • Drug: Comparator
    comparison of different dosages of drug versus comparator
    Other Name: Foster
  • Experimental: Glyco 25
    BDP/FF (400/24 daily)+ Glyco 25µg daily
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco 50
    BDP/FF (400/24 daily)+ Glyco 50 µg daily
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco 100
    BDP/FF (400/24 daily)+ Glyco 100µg daily
    Intervention: Drug: Glycopyrrolate
  • Active Comparator: BDP/FF 400/24
    BDP/FF 400/24
    Intervention: Drug: Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
July 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01476813
CCD-1106-PR-0066
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Dave Singh, MD Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
Chiesi Farmaceutici S.p.A.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP