Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
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
1 other identifier
interventional
271
1 country
50
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Shorter than P25 for phase_4
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
November 17, 2011
CompletedNovember 17, 2011
October 1, 2011
1 year
March 25, 2009
October 12, 2011
October 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
24 weeks
Study Arms (2)
Omalizumab
EXPERIMENTALThe determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Placebo
PLACEBO COMPARATORPlacebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Genentech, Inc.collaborator
Study Sites (50)
Jasper Summit Research, LLC
Jasper, Alabama, 35501, United States
Allergy Asthma and Immunology Center of Alaska
Anchorage, Alaska, 99508, United States
Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
Scottsdale, Arizona, 85251, United States
Waren W. Pleskow, MD
Encinitas, California, 92024, United States
William Ebbeling, MD, Inc
Fresno, California, 93720, United States
Pediatric Care Medical Group, Inc
Huntington Beach, California, 92647, United States
California Allergy & Asthma Medical Group
Palmdale, California, 93551, United States
Allergy Associates Medical Group, Inc
San Diego, California, 92120, United States
Sansum Clinic
Santa Barbara, California, 93110, United States
Allergy & Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Innovative Research of West Florida, Inc
Clearwater, Florida, 33756, United States
Palm Spring Research Institute, Inc
Hialeah, Florida, 33012, United States
Integrity Research, LLC
Pensacola, Florida, 32514, United States
Hugh Windom, MD, PA
Sarasota, Florida, 34233, United States
South Miami Clinical Research, LLC
South Miami, Florida, 33143, United States
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, 31707, United States
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, 61761, United States
Chest Medicine Clinical Services
Skokie, Illinois, 60076, United States
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208, United States
Kansas City Allergy & Asthma Center
Overland Park, Kansas, 66210, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Abraham Research, PLLC
Crescent Springs, Kentucky, 41017, United States
Rx R&D
Metairie, Louisiana, 70002, United States
Acadiana Medicine Clinic
Opelousas, Louisiana, 70570, United States
Paul A Shapero, MD
Bangor, Maine, 04401, United States
Chesapeake Clinical Research
Baltimore, Maryland, 21236, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Maimonides Medical Center, Division of Pediatric Pulmonology
Brooklyn, New York, 11219, United States
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, 14618, United States
Alan Kaufman, MD
The Bronx, New York, 10465, United States
Allergy & Asthma Center of NC, PA
High Point, North Carolina, 27262, United States
Wilmington Medical Research
Wilmington, North Carolina, 28401, United States
Allergy and Respiratory Center
Canton, Ohio, 44718, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Oklahoma Allergy & Asthma Clinic
Oklahoma City, Oklahoma, 73104, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Baker Allergy Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, 19107, United States
AAPRI Clinical Research Institute
Lincoln, Rhode Island, 02865, United States
Pediatric Pulmonary Associates of North Texas, PA
Dallas, Texas, 75230, United States
Western Sky Medical Research
El Paso, Texas, 79903, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132, United States
Allergy & Asthma Associates
Houston, Texas, 77054, United States
Lynchburg Pulmonary Associates
Lynchburg, Virginia, 24501, United States
Virginia Adult and Pediatric Allergy and Asthma PC
Richmond, Virginia, 23229, United States
Asthma Inc.
Seattle, Washington, 98105, United States
Pulmonary and Research Associates
Spokane, Washington, 99204, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2009
First Posted
March 27, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
November 17, 2011
Results First Posted
November 17, 2011
Record last verified: 2011-10