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Trial record 19 of 186 for:    GLYCOPYRROLATE

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

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.
 
ClinicalTrials.gov Identifier: NCT01476813
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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)

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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
Actual Primary Completion Date : September 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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

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
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United Kingdom
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Dave Singh, MD Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

Additional Information:
Publications of Results:
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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 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Access Criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
URL: https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Additional relevant MeSH terms:
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Glycopyrrolate
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs