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)

Study Identifier:
CLI-05993BA1-02
ClinicalTrials.gov Identifier:
NCT03590379
EudraCT Identifier:
2017-004405-41
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
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Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: CHF 5993 DPI
  • Drug: CHF5993 pMDI
  • Drug: CHF 1535 pMDI
  • Drug: Placebo DPI
  • Drug: Placebo pMDI
Date
Jun 2018 - Oct 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 85 Years
Requirements Information
Inclusion and Exclusion 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;
Healthy Volunteers
No

Protocol 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

Study Locations

Location
Status
Location
Medical Center Convex EOOD
Sofia, Bulgaria, 1680
Status
N/A

Study Publications

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.