Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD

PHASE2CompletedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

September 30, 2012

Study Completion Date

January 31, 2013

Conditions
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

CHF1535 + CHF5992 dose 1 BID

CHF1535 + CHF5992 dose 1 BID for 14 days

DRUG

CHF1535 + CHF5992 dose2 BID

CHF1535 + CHF5992 dose 2 BID for 14 days

DRUG

CHF1535 daily dose

CHF1535 daily dose for 14 days

Trial Locations (6)

1122

Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő, Budapest

1407

"Hospital Lozenets", Sofia

127018

State Budgetary Healthcare Institution of Moscow city, Moscow

D-12165

Praxis Dr. Kampschulte, Berlin

15-003

ISPL Centrum Medyczne Robert M. Mróz, Bialystok

M23 9QZ

Medicines Evaluation Unit, Langley Building, Manchester

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT01584505 - Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD | Biotech Hunter | Biotech Hunter