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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
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 18, 2011
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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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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