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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476813
First Posted: November 22, 2011
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
  Purpose
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Glycopyrrolate Drug: Comparator Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

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

Enrollment: 281
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

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 Submitted: November 18, 2011
First Posted: November 22, 2011
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