Clinical trial 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)
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 366
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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;

Primary outcomes:
measure: 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
timeFrame: Day 28
measure: Trough FEV1 at 24 hours (L) on dosing Day 28.
timeFrame: Day 28
Secondary outcomes:
measure: Change from baseline in pre-dose morning FEV1 (L) on Day 28
timeFrame: from Baseline to Day 28
measure: Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
timeFrame: from Baseline to Day 28
measure: Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
timeFrame: from Baseline to Day 1
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical Center Convex EOOD
Study officials:
affiliation: Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
name: Kai-Michael Beeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.