Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
TRI-D
A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease
2 other identifiers
interventional
366
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Jun 2018
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
June 6, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2019
CompletedApril 12, 2021
April 1, 2021
4 months
June 6, 2018
April 8, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients
Day 28
Trough FEV1 at 24 hours (L) on dosing Day 28.
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients
Day 28
Secondary Outcomes (3)
Change from baseline in pre-dose morning FEV1 (L) on Day 28
from Baseline to Day 28
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
from Baseline to Day 28
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
from Baseline to Day 1
Study Arms (3)
CHF 5993 DPI
EXPERIMENTALBDP/FF/GB DPI 100/6/12,5 mcg
CHF 5993 pMDI
ACTIVE COMPARATORBDP/FF/GB pMDI 100/6/12,5 mcg
CHF 1535 pMDI
ACTIVE COMPARATORBDP/FF pMDI 100/6 mcg
Interventions
CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
Eligibility Criteria
You may qualify if:
- Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;
- Current smokers or ex-smokers;
- A Post-bronchodilator FEV1 ≥30% and \<80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) \< 0.7;
- Patients' COPD therapy (stable regimen at least 30 days before screening) with either:
- Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination
- Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- Inhaled long-acting muscarinic antagonist alone.
You may not qualify if:
- Pregnant and lactating women;
- Diagnosis of asthma;
- Known respiratory disorders other than COPD;
- Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
- Patients who have clinically significant cardiovascular condition;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center Convex EOOD
Sofia, 1680, Bulgaria
Related Publications (1)
Beeh KM, Kuna P, Corradi M, Viaud I, Guasconi A, Georges G. Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2021 Jan 14;16:79-89. doi: 10.2147/COPD.S291030. eCollection 2021.
PMID: 33488071RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai-Michael Beeh, MD
Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
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
June 6, 2018
First Posted
July 18, 2018
Study Start
June 15, 2018
Primary Completion
October 16, 2018
Study Completion
March 6, 2019
Last Updated
April 12, 2021
Record last verified: 2021-04
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.