Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

Chiesi

Status and phase: Completed; Phase 3

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Drug: CHF 5993 100/6/12.5 µg; Drug: 160 µg budesonide + 4.5 µg formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03197818

China (Other Identifier)

South Korea (Other Identifier)

CCD-5993AA1-14

Taiwan (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

Enrollment: 990 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female adults aged > 40 years with a diagnosis of COPD
• Current smokers or ex-smokers
• A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
• At least one exacerbation in the 12 months preceding the screening visit

Exclusion criteria

• Pregnant or lactating women
• Diagnosis of asthma, history of allergic rhinitis or atopy
• Patients treated for exacerbations in the 4 weeks prior to screening visit
• Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
• Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
• Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
• Known respiratory disorders other than COPD
• Patients who have clinically significant cardiovascular condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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990 participants in 2 patient groups

CHF 5993 100/6/12.5 µg

Experimental group

Description:

Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)

Treatment:

Drug: CHF 5993 100/6/12.5 µg

Symbicort Turbuhaler 160/4.5 µg

Active Comparator group

Description:

Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)

Treatment:

Drug: 160 µg budesonide + 4.5 µg formoterol fumarate