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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)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
Bulgaria
Study Type
Interventional
Intervention
CHF 5993 DPI
CHF5993 pMDI
CHF 1535 pMDI
Placebo DPI
Placebo pMDI
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;

Sites / Locations

  • Medical Center Convex EOOD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CHF 5993 DPI

CHF 5993 pMDI

CHF 1535 pMDI

Arm Description

BDP/FF/GB DPI 100/6/12,5 mcg

BDP/FF/GB pMDI 100/6/12,5 mcg

BDP/FF pMDI 100/6 mcg

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change from baseline in pre-dose morning FEV1 (L) on Day 28
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

Full Information

First Posted
June 6, 2018
Last Updated
April 8, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03590379
Brief Title
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)
Acronym
TRI-D
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
March 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5993 DPI
Arm Type
Experimental
Arm Description
BDP/FF/GB DPI 100/6/12,5 mcg
Arm Title
CHF 5993 pMDI
Arm Type
Active Comparator
Arm Description
BDP/FF/GB pMDI 100/6/12,5 mcg
Arm Title
CHF 1535 pMDI
Arm Type
Active Comparator
Arm Description
BDP/FF pMDI 100/6 mcg
Intervention Type
Drug
Intervention Name(s)
CHF 5993 DPI
Intervention Description
BDP/FF/GB DPI
Intervention Type
Drug
Intervention Name(s)
CHF5993 pMDI
Intervention Description
BDP/FF/GB pMDI
Intervention Type
Drug
Intervention Name(s)
CHF 1535 pMDI
Intervention Description
BDP/FF pMDI
Intervention Type
Drug
Intervention Name(s)
Placebo DPI
Intervention Description
CHF 5993 DPI matched placebo
Intervention Type
Drug
Intervention Name(s)
Placebo pMDI
Intervention Description
CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Day 28
Title
Trough FEV1 at 24 hours (L) on dosing Day 28.
Description
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
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change from baseline in pre-dose morning FEV1 (L) on Day 28
Description
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Time Frame
from Baseline to Day 28
Title
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
Description
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Time Frame
from Baseline to Day 28
Title
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
Description
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Time Frame
from Baseline to Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Michael Beeh, MD
Organizational Affiliation
Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria

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
33488071
Citation
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.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004405-41/results
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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)

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