Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Bronchial Asthma
Interventions
DRUG

salbutamol 100 mcg

To be used as needed for symptom relief

DRUG

BDP/salbutamol HFA pMDI

Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo

DRUG

BDP/salbutamol CFC pMDI

Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo

Trial Locations (25)

16129

Unità Dipartimentale di Fisiopatologia Respiratoria -Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate, Genova

Unità Operativa Complessa di Clinica fisiologica e Pneumologia - Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate, Genova

28007

Hospital General Universitario Gregorio Marañón, Madrid

35127

Dipartimento di Medicina Ambientale e Sanità Pubblica-Sede di Medicina del Lavoro Servizio di Fisiopatologia Respiratoria, Padua

37012

Servizio di Fisiopatologia Respiratoria Diagnostica Allergologica e Biologia Respiratoria Endoscopica e Toracica U.O.C. di Pneumologia Ospedale Orlandi, Bussolengo

50082

Department of Pediatrics and laboratory diagnostics, Dniepropetrovsk State Medical Academy City Clinical Hospital No. 8. Pulmonology Department. 55, Krivoi Rog

56100

Malattie dell'Apparato Respiratorio - Università degli Studi di Pisa Ospedale Cisanello, Pisa

61008

Department of Therapy of Kharkov Medical Academy of Postgraduate Education City Multifield Clinical Hospital n° 25, Kharkiv

61022

Central Military Hospital of North Region. Pulmonological Department, Kharkiv

Department of propaedeutics of internal diseases #1. Kharkov State Medical University., Kharkiv

61035

Pulmonological Department # 2 City Clinical Hospital # 13, Kharkiv

Pulmonological Department of the Institute of Therapy Ukrainian Academy of Medical Science, Kharkiv

61037

Department of General Practice - Family Medecine Medical Academy of post-graduate education. City Clinical Hospital N° 17, Kharkiv

79010

Department of Hospital Therapy, Lviv State Medical University named by Danylo Galytsky, Lviv Regional Clinical Hospital, Lviv

91045

Department of Hospital Therapy of Lugansk State Medical Institute, Luhansk

119048

City Clinical Hospital № 61, Pulmonology Department, Moscow

125315

"Central Clinical Hospital №1 OAORZD,Pulmonology Department", Moscow

150010

Clinical Hospital № 2, Pulmonology Department, Yaroslavl

150030

Clinical Hospital № 8, Pulmonology Department, Yaroslavl

150062

Regional Clinical Hospital, Department of Therapeutics of Post Graduate, Yaroslavl Medical Academy, Yaroslavl

61022,

Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital, Kharkiv

03680

Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease of the Institute of Phtisiology and Pulmonology Academy of Medical Sciences of the Ukraine, Kiev

Institute of Phthisiology and Pulmonology Acedemy of Medical Science of the Ukraine, Kiev

Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine, Kiev

01133

General Therapy Clinic Central Military Clinical Hospital of Ministry of Defenses of Ukraine, Kyiv

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT00528723 - Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma | Biotech Hunter | Biotech Hunter