Skip to main content
OpenTrials
Completed

NCT Number: NCT03590379

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)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center Convex EOOD

Sofia, 1680, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

CHF 5993 DPI

Drug

BDP/FF/GB DPI

CHF5993 pMDI

Drug

BDP/FF/GB pMDI

CHF 1535 pMDI

Drug

BDP/FF pMDI

Placebo DPI

Drug

CHF 5993 DPI matched placebo

Placebo pMDI

Drug

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

Primary outcomes

  1. 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

    Time frame: 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

  2. Trough FEV1 at 24 hours (L) on dosing Day 28.

    Time frame: 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 outcomes

  1. Change from baseline in pre-dose morning FEV1 (L) on Day 28

    Time frame: from Baseline to Day 28

    To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

  2. Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28

    Time frame: from Baseline to Day 28

    To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

  3. Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1

    Time frame: from Baseline to Day 1

    To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: TRI-D

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.