Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
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
1 other identifier
interventional
281
1 country
1
Brief Summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 29, 2021
October 1, 2021
6 months
November 18, 2011
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Aera under curve FEV1 AUC 0-12h
day 1 and 7 of treatment period
Study Arms (4)
Glyco 25
EXPERIMENTALBDP/FF (400/24 daily)+ Glyco 25µg daily
Glyco 50
EXPERIMENTALBDP/FF (400/24 daily)+ Glyco 50 µg daily
Glyco 100
EXPERIMENTALBDP/FF (400/24 daily)+ Glyco 100µg daily
BDP/FF 400/24
ACTIVE COMPARATORBDP/FF 400/24
Interventions
comparison of different dosages of drug versus comparator
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnant or lactating women
- Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
- concommitant diseases impacting feasibility or safety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom
Related Publications (1)
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.
PMID: 27109816RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, MD
Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 22, 2011
Study Start
March 1, 2012
Primary Completion
September 1, 2012
Study Completion
July 1, 2013
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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.