2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients (TRIBUTE)
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.
Outpatients attending the hospital clinics/study centres will be recruited. Patients with severe and very severe COPD airflow obstruction according to GOLD 2014 criteria. A total of approximately 2192 patients will need to be screened in order to obtain 1534 (767 per arm) randomized and evaluable patients. Approximately 200 sites will be involved worldwide.
Each patient will perform a total of 8 clinic visits (V0 to V7) during the study.
The Primary objective is to demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
The Secondary objectives are:
1. To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures;
2. To assess the safety and the tolerability of the study treatments.
A 2-week open-label run-in period under Ultibro® followed by a 52-week randomised treatment period.
The trial design will be optimised to measure exacerbation rates by using the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), developed means of collecting patient-reported outcome (PRO) data, which helps to capture the frequency of exacerbations.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 1532 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients
Actual Study Start Date: May 29, 2015
Actual Primary Completion Date: July 10, 2017
Actual Study Completion Date: July 10, 2017
- Experimental: CHF 5993 + Ultibro matched placebo
- Active Comparator: Ultibro + CHF 5993 matched placebo
- Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial.
|Date last updated at source||2018-02-20|
|Study start date||2015-05-29|
|Estimated primary completion date||2017-07-10|