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

Phase 3CompletedNCT01917331

Chiesi Farmaceutici S.p.A.1,368 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,368

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Beclometasone/Formoterol/GlycopyrrolateDRUG

Active drug tested

Beclometasone/FormoterolDRUG

Active comparator

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr Beatrix BALINT

Szeged, Hungary

Outcomes

Primary Outcomes

Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26

* Change from baseline in pre-dose morning FEV1 at Week 26. * Change from baseline to the 2-hour post-dose value of FEV1 at Week 26. * TDI focal score at Week 26

Time frame: week 26

Secondary Outcomes

COPD exacerbation rate

Moderate and severe COPD exacerbation rate over 52 weeks of treatment

Time frame: week 52

Data from ClinicalTrials.gov

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