Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

PHASE4CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Persistent Allergic Asthma
Interventions
DRUG

Omalizumab

Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

DRUG

Placebo

Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

Trial Locations (50)

10465

Alan Kaufman, MD, The Bronx

11219

Maimonides Medical Center, Division of Pediatric Pulmonology, Brooklyn

14618

Allergy Asthma Immunology of Rochester Research Center, Rochester

19107

Asthma Allergy & Pulmonary Associates, Philadelphia

21236

Chesapeake Clinical Research, Baltimore

23229

Virginia Adult and Pediatric Allergy and Asthma PC, Richmond

24501

Lynchburg Pulmonary Associates, Lynchburg

27262

Allergy & Asthma Center of NC, PA, High Point

28401

Wilmington Medical Research, Wilmington

31707

Georgia Pollens Clinical Research Centers, Inc, Albany

32514

Integrity Research, LLC, Pensacola

33012

Palm Spring Research Institute, Inc, Hialeah

33143

South Miami Clinical Research, LLC, South Miami

33756

Innovative Research of West Florida, Inc, Clearwater

34233

Hugh Windom, MD, PA, Sarasota

35501

Jasper Summit Research, LLC, Jasper

41017

Abraham Research, PLLC, Crescent Springs

44718

Allergy and Respiratory Center, Canton

45242

New Horizons Clinical Research, Cincinnati

46208

Clinical Research Center of Indiana, Indianapolis

48197

Respiratory Medicine Research Institute of Michigan, Ypsilanti

55402

Clinical Research Institute, Minneapolis

59808

Montana Medical Research, Inc., Missoula

60076

Chest Medicine Clinical Services, Skokie

61761

Sneeze, Wheeze and Itch Associates, LLC, Normal

63141

The Clinical Research Center, LLC, St Louis

66210

Kansas City Allergy & Asthma Center, Overland Park

66606

Cotton-O'Neil Clinical Research Center, Topeka

70002

Rx R&D, Metairie

70570

Acadiana Medicine Clinic, Opelousas

73104

Oklahoma Allergy & Asthma Clinic, Oklahoma City

73120

Allergy, Asthma and Clinical Research Center, Oklahoma City

75230

Pediatric Pulmonary Associates of North Texas, PA, Dallas

76132

North Texas Institute for Clinical Trials, Fort Worth

77054

Allergy & Asthma Associates, Houston

79903

Western Sky Medical Research, El Paso

85251

Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD, Scottsdale

92024

Waren W. Pleskow, MD, Encinitas

92120

Allergy Associates Medical Group, Inc, San Diego

92647

Pediatric Care Medical Group, Inc, Huntington Beach

93110

Sansum Clinic, Santa Barbara

93551

California Allergy & Asthma Medical Group, Palmdale

93720

William Ebbeling, MD, Inc, Fresno

94598

Allergy & Asthma Clinical Research, Inc., Walnut Creek

97035

Baker Allergy Asthma and Dermatology Research Center, LLC, Lake Oswego

98105

Asthma Inc., Seattle

99204

Pulmonary and Research Associates, Spokane

99508

Allergy Asthma and Immunology Center of Alaska, Anchorage

04401

Paul A Shapero, MD, Bangor

02865

AAPRI Clinical Research Institute, Lincoln

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY