Dose Finding Study of CHF 4226 for Treating Patients With COPD

PHASE2CompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

carmoterol (CHF 4226)

"carmoterol pMDI 2.0 μg once a day, in the morning~(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)"

DRUG

carmoterol (CHF 4226)

"carmoterol pMDI 1.0 μg once a day, in the morning~(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))"

DRUG

carmoterol (CHF 4226)

"carmoterol pMDI 4.0 μg once a day, in the morning~(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)"

DRUG

salmeterol

Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)

DRUG

placebo

Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)

Trial Locations (50)

7530

Tiervlei Trial Center, Karl Bremer Hospital, Bellville

7700

UCT Lung Institute, Mowbray

14057

Medars GmbH, Berlin

15030

Nemocnice Na Homolce Plicni ambulance, Prague

15565

IFG GmbH, Rüdersdorf

20535

Pneumologisches Forschungsinstitut Niederlassung Hamburg, Hamburg

21502

Lungenzentrum Geesthacht, Geesthacht

22927

Pneumologisches Forschungsinstitut GmbH, Großhansdorf

28625

Carolina Pharmaceutical Research, Statesville

29406

Lowcountry Lung and Critical Care, PA, North Charleston

32720

University Clinical Research - DeLand, LLC, DeLand

33409

Palm Beach Research Center, West Palm Beach

33603

Clinical Research of West Florida, Inc., Tampa

33765

Clinical Research of West Florida, Clearwater

39112

SMO, MD GmbH, Magdeburg

43560

Toledo Center for Clinical Research, Sylvania

45242

New Horizons Clinical Research, Cincinnati

46011

Community Clinical Research Center, Anderson

48106

ClinSite, LLC, Ann Arbor

48187

ClinSite, Canton

53792

University of Wisconsin-Allergy/Asthma, Madison

60540

Edward Hospital and Helath Services, Center for Clinical Trials, Naperville

72401

Clopton Clinic, Jonesboro

75708

The University of Texas Health Center at Tyler, Tyler

77450

Breath of Life Research Institute, Katy

79124

Amarillo Center for Clinical Research, Ltd., Amarillo

80206

National Jewish Medical and Research Center, Denver

92103

UCSD - Clinical Trials Center, San Diego

92120

Institute of Healthcare Assessment Inc., San Diego

93720

ABM Research Center, Fresno

97504

Clinical Research Institute of Southern Oregon PC, Medford

Pulmonary Consultants - Research Department, Medford

500326

Spitalul Clinic Judetean de Urgenta Brasov, Brasov

900002

Spitalul de Pneumoftiziologie Constanta, Constanța

08003

Delaware Valley Clinical Research, Cherry Hill

266 01

Ordinace pro nemoci dychaciho ustroji, Beroun

284 01

OTRAN, Kutná Hora

Plicni a alergologicka ambulance, Kutná Hora

310 02

Pneumolog, internista, Lovosice

130 00

Plicni ambulance, Praha 3 - Zizkov

337 01

Plicni ambulance Rokycany, Rokycany

04207

Robert-Koch-Klinik, Leipzig

80-433

Medcare Specjalistyczna Opieka Medyczna NZOZ, Gdansk

80-847

NZOZ Non-nocere, Gdansk

90-153

Klinika Pulmonologii i Alergologii, Lodz

32-100

SPZOZ w Proszowicach Oddzial Chorob Pluc, Proszowice

010457

"Spitalul de Urgenta Prof. Dr. Dimitrie Gerota", Bucharest

010825

"Spitalul Clinic de Urgenta Militar Central Davila", Bucharest

011172

"Spitalul Clinic Sf. Maria", Bucharest

050159

"Institutul National de Pneumoftisiologie M. Nasta", Bucharest

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chiesi USA, Inc.

INDUSTRY

lead

Chiesi Farmaceutici S.p.A.

INDUSTRY