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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Beclometasone/Formoterol/Glycopyrrolate; Drug: Beclometasone/Formoterol

• Registration Number: NCT01917331
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-06
• Study Start: 2014-03
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1368

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beclometasone/Formoterol/Glycopyrrolate	Beclometasone/Formoterol/Glycopyrrolate	CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
Beclometasone/Formoterol	Beclometasone/Formoterol	Foster® 100/6 mcg 2 inhalations bid

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
COPD exacerbation rate	week 52	Moderate and severe COPD exacerbation rate over 52 weeks of treatment

Trial Locations

Locations (1)

Dr Beatrix BALINT; 🇭🇺 Szeged, Hungary