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