Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Glycopyrrolate
Glycopyrrolate
Glycopyrrolate
Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility 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
Sites / Locations
- Medicines Evaluation Unit Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Glyco 25
Glyco 50
Glyco 100
BDP/FF 400/24
Arm Description
BDP/FF (400/24 daily)+ Glyco 25µg daily
BDP/FF (400/24 daily)+ Glyco 50 µg daily
BDP/FF (400/24 daily)+ Glyco 100µg daily
BDP/FF 400/24
Outcomes
Primary Outcome Measures
Aera under curve FEV1 AUC 0-12h
Secondary Outcome Measures
Full Information
NCT ID
NCT01476813
First Posted
November 18, 2011
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01476813
Brief Title
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glyco 25
Arm Type
Experimental
Arm Description
BDP/FF (400/24 daily)+ Glyco 25µg daily
Arm Title
Glyco 50
Arm Type
Experimental
Arm Description
BDP/FF (400/24 daily)+ Glyco 50 µg daily
Arm Title
Glyco 100
Arm Type
Experimental
Arm Description
BDP/FF (400/24 daily)+ Glyco 100µg daily
Arm Title
BDP/FF 400/24
Arm Type
Active Comparator
Arm Description
BDP/FF 400/24
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Foster+GLyco 25
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Foster+GLyco 50
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Foster+GLyco 100
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
Comparator
Other Intervention Name(s)
Foster
Intervention Description
comparison of different dosages of drug versus comparator
Primary Outcome Measure Information:
Title
Aera under curve FEV1 AUC 0-12h
Time Frame
day 1 and 7 of treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Singh, MD
Organizational Affiliation
Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicines Evaluation Unit Ltd.
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Citations:
PubMed Identifier
27109816
Citation
Singh D, Schroder-Babo W, Cohuet G, Muraro A, Bonnet-Gonod F, Petruzzelli S, Hoffmann M, Siergiejko Z; TRIDENT study investigators. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study). Respir Med. 2016 May;114:84-90. doi: 10.1016/j.rmed.2016.03.018. Epub 2016 Mar 26.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-003588-31
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/CSR_Synopsis_CCD-1106-PR-0066.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register
Learn more about this trial
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
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