Chronic Obstructive Pulmonary Disease
Conditions
Keywords
spirometry, severe COPD, lung disease, fixed combination
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.
Interventions
Active drug tested
Active comparator
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| COPD exacerbation rate | week 52 | Moderate and severe COPD exacerbation rate over 52 weeks of treatment |
Countries
Hungary
Outcome results
None listed