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

NCT02579850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1532

Last updated 2021-10-29

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Mario Scuri, MD · Chiesi Farmaceutici S.p.A.

  • Nicolas Roche, Pr · Hopitaux Universitaires Paris Centre - Groupe Hospitalier Cochin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-29
Primary Completion
2017-07-10
Completion
2017-07-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579850 on ClinicalTrials.gov