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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,532

Participants

Timeline

Start Date

May 29, 2015

Primary Completion Date

July 10, 2017

Study Completion Date

July 10, 2017

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)

Trial Locations (1)

43123

Chiesi Farmaceutici S.p.A., Parma

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT02579850 - 2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients | Biotech Hunter | Biotech Hunter