Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease
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. ;
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