NCT02579850

2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients

52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,532 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF 5993 + Ultibro matched placebo	Active medication treatment CHF 5993 and Ultibro matched placebo administered twice a day
DRUG	Ultibro + CHF 5993 matched placebo	Active medication treatment Ultibro and CHF 5993 matched placebo administered twice a day
PROCEDURE	Central spirometry	Central spirometry to assess forced expiratory volume at one second and forced vital capacity
OTHER	COPD assessment test	COPD assessment test (CAT) at visit 1
PROCEDURE	Local laboratory Assessments	ECG + Standard Haematology and Biochemistry
OTHER	Saint George's Respiratory Questionnaire	Saint George's Respiratory Questionnaire
OTHER	EXACT-pro questionnaire	daily from randomization (Visit 2) to end of study (Visit 7)

Timeline

• Start date: 2015-05-29
• Primary completion: 2017-07-10
• Completion: 2017-07-10
• First posted: 2015-10-20
• Last updated: 2021-10-29

Locations

1 site across 1 country: Italy