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

Persistent Allergic Asthma Clinical Trial

Official title:

A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870584
• Other study ID #: CIGE025AUS33
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: October 12, 2011
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Total Asthma Control Test (ACT) score of =19 plus at least one of the following in the 4 weeks preceding visit 1, on average:

• Symptoms > 2 days/week

• Night-time awakenings =1 time/week

• Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) = 80% predicted

Exclusion Criteria:

• History of intubation for asthma.

• An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).

• Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Other protocol-defined inclusion/exclusion criteria applied

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Persistent Allergic Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Georgia Pollens Clinical Research Centers, Inc	Albany	Georgia
United States	Allergy Asthma and Immunology Center of Alaska	Anchorage	Alaska
United States	Chesapeake Clinical Research	Baltimore	Maryland
United States	Paul A Shapero, MD	Bangor	Maine
United States	Alan Kaufman, MD	Bronx	New York
United States	Maimonides Medical Center, Division of Pediatric Pulmonology	Brooklyn	New York
United States	Allergy and Respiratory Center	Canton	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Innovative Research of West Florida, Inc	Clearwater	Florida
United States	Abraham Research, PLLC	Crescent Springs	Kentucky
United States	Pediatric Pulmonary Associates of North Texas, PA	Dallas	Texas
United States	Western Sky Medical Research	El Paso	Texas
United States	Waren W. Pleskow, MD	Encinitas	California
United States	North Texas Institute for Clinical Trials	Fort Worth	Texas
United States	William Ebbeling, MD, Inc	Fresno	California
United States	Palm Spring Research Institute, Inc	Hialeah	Florida
United States	Allergy & Asthma Center of NC, PA	High Point	North Carolina
United States	Allergy & Asthma Associates	Houston	Texas
United States	Pediatric Care Medical Group, Inc	Huntington Beach	California
United States	Clinical Research Center of Indiana	Indianapolis	Indiana
United States	Jasper Summit Research, LLC	Jasper	Alabama
United States	Baker Allergy Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	AAPRI Clinical Research Institute	Lincoln	Rhode Island
United States	Lynchburg Pulmonary Associates	Lynchburg	Virginia
United States	Rx R&D	Metairie	Louisiana
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Montana Medical Research, Inc.	Missoula	Montana
United States	Sneeze, Wheeze and Itch Associates, LLC	Normal	Illinois
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Oklahoma Allergy & Asthma Clinic	Oklahoma City	Oklahoma
United States	Acadiana Medicine Clinic	Opelousas	Louisiana
United States	Kansas City Allergy & Asthma Center	Overland Park	Kansas
United States	California Allergy & Asthma Medical Group	Palmdale	California
United States	Integrity Research, LLC	Pensacola	Florida
United States	Asthma Allergy & Pulmonary Associates	Philadelphia	Pennsylvania
United States	Virginia Adult and Pediatric Allergy and Asthma PC	Richmond	Virginia
United States	Allergy Asthma Immunology of Rochester Research Center	Rochester	New York
United States	The Clinical Research Center, LLC	Saint Louis	Missouri
United States	Allergy Associates Medical Group, Inc	San Diego	California
United States	Sansum Clinic	Santa Barbara	California
United States	Hugh Windom, MD, PA	Sarasota	Florida
United States	Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD	Scottsdale	Arizona
United States	Asthma Inc.	Seattle	Washington
United States	Chest Medicine Clinical Services	Skokie	Illinois
United States	South Miami Clinical Research, LLC	South Miami	Florida
United States	Pulmonary and Research Associates	Spokane	Washington
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Allergy & Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Wilmington Medical Research	Wilmington	North Carolina
United States	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment	The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.	Baseline and 24 weeks	No
Secondary	Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks	The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.	24 weeks	No

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