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)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03590379

Acronym

TRI-D

Enrollment

366

Registered

2018-07-18

Start date

2018-06-15

Completion date

2019-03-06

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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

Interventions

DRUGCHF 5993 DPI

BDP/FF/GB DPI

DRUGCHF5993 pMDI

BDP/FF/GB pMDI

DRUGCHF 1535 pMDI

BDP/FF pMDI

DRUGPlacebo DPI

CHF 5993 DPI matched placebo

DRUGPlacebo pMDI

CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
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	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.	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

Measure	Time frame	Description
Change from baseline in pre-dose morning FEV1 (L) on Day 28	from Baseline to 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	from Baseline to 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	from Baseline to Day 1	To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026