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)

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590379
• Other study ID #: CLI-05993BA1-02
• Secondary ID: 2017-004405-41
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: April 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: March 6, 2019
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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 ß2-agonist/long-acting muscarinic antagonist (free or fixed) combination
• Inhaled corticosteroids/long-acting ß2-agonist (free or fixed) combination
• Inhaled long-acting ß2-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;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• CHF 5993 DPI
BDP/FF/GB DPI
• CHF5993 pMDI
BDP/FF/GB pMDI
• CHF 1535 pMDI
BDP/FF pMDI
• Placebo DPI
CHF 5993 DPI matched placebo
• Placebo pMDI
CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)

Locations

Country	Name	City	State
Bulgaria	Medical Center Convex EOOD	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Bulgaria, 

References & 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 Ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	from Baseline to Day 28
Secondary	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.	from Baseline to Day 28
Secondary	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.	from Baseline to Day 1

External Links

•   Study Record on EU Clinical Trials Register including results