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) (TRI-D)

Chiesi

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: CHF5993 pMDI; Drug: CHF 5993 DPI; Drug: Placebo pMDI; Drug: Placebo DPI; Drug: CHF 1535 pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03590379

CLI-05993BA1-02

2017-004405-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 366 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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366 participants in 3 patient groups

CHF 5993 DPI

Experimental group

Description:

BDP/FF/GB DPI 100/6/12,5 mcg

Treatment:

Drug: CHF 5993 DPI

Drug: Placebo pMDI

CHF 5993 pMDI

Active Comparator group

Description:

BDP/FF/GB pMDI 100/6/12,5 mcg

Treatment:

Drug: CHF5993 pMDI

Drug: Placebo DPI

CHF 1535 pMDI

Active Comparator group

Description:

BDP/FF pMDI 100/6 mcg

Treatment:

Drug: CHF 1535 pMDI

Drug: Placebo DPI