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

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ClinicalTrials.gov Identifier: NCT01476813
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):

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
Pulmonary Disease, Chronic Obstructive Drug: Glycopyrrolate Drug: Comparator 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  (Clinical Trial)
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 : March 2012
Primary Completion Date : September 2012
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Foster+GLyco 25
Experimental: Glyco 50
BDP/FF (400/24 daily)+ Glyco 50 µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Name: Foster+GLyco 50
Experimental: Glyco 100
BDP/FF (400/24 daily)+ Glyco 100µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Name: Foster+GLyco 100
Active Comparator: BDP/FF 400/24
BDP/FF 400/24
Drug: Comparator
comparison of different dosages of drug versus comparator
Other Name: Foster


Outcome Measures

Primary Outcome Measures :
  1. Aera under curve FEV1 AUC 0-12h [ Time Frame: day 1 and 7 of treatment period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476813


Locations
United Kingdom
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
More Information

Additional Information:
Publications:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01476813     History of Changes
Other Study ID Numbers: CCD-1106-PR-0066
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs