Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Chiesi

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Beclometasone/Formoterol

Drug: Beclometasone/Formoterol/Glycopyrrolate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01917331

CCD-1207-PR-0091

Details and patient eligibility

About

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

Full description

This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients.

Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment.

During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Enrollment

1,368 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 < 0.7
At least one exacerbation in the 12 months preceding the screening visit

Exclusion criteria

Pregnant or lactating women
Diagnosis of asthma or history of allergic rhinitis or atopy
Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
Patients treated for exacerbations in the 4 weeks prior to 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 PRN
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