Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
- Registration Number
- NCT00870584
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 271
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omalizumab Omalizumab The 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 Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
- Primary Outcome Measures
Name Time Method Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment Baseline and 24 weeks 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.
- Secondary Outcome Measures
Name Time Method Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks 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.
Trial Locations
- Locations (50)
Palm Spring Research Institute, Inc
🇺🇸Hialeah, Florida, United States
Paul A Shapero, MD
🇺🇸Bangor, Maine, United States
Pediatric Pulmonary Associates of North Texas, PA
🇺🇸Dallas, Texas, United States
Clinical Research Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Allergy & Asthma Associates
🇺🇸Houston, Texas, United States
Kansas City Allergy & Asthma Center
🇺🇸Overland Park, Kansas, United States
Allergy Associates Medical Group, Inc
🇺🇸San Diego, California, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
Pediatric Care Medical Group, Inc
🇺🇸Huntington Beach, California, United States
William Ebbeling, MD, Inc
🇺🇸Fresno, California, United States
AAPRI Clinical Research Institute
🇺🇸Lincoln, Rhode Island, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
🇺🇸Scottsdale, Arizona, United States
Waren W. Pleskow, MD
🇺🇸Encinitas, California, United States
Jasper Summit Research, LLC
🇺🇸Jasper, Alabama, United States
Allergy Asthma and Immunology Center of Alaska
🇺🇸Anchorage, Alaska, United States
Innovative Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Abraham Research, PLLC
🇺🇸Crescent Springs, Kentucky, United States
Hugh Windom, MD, PA
🇺🇸Sarasota, Florida, United States
Chest Medicine Clinical Services
🇺🇸Skokie, Illinois, United States
Chesapeake Clinical Research
🇺🇸Baltimore, Maryland, United States
South Miami Clinical Research, LLC
🇺🇸South Miami, Florida, United States
Rx R&D
🇺🇸Metairie, Louisiana, United States
Acadiana Medicine Clinic
🇺🇸Opelousas, Louisiana, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Respiratory Medicine Research Institute of Michigan
🇺🇸Ypsilanti, Michigan, United States
Allergy Asthma Immunology of Rochester Research Center
🇺🇸Rochester, New York, United States
The Clinical Research Center, LLC
🇺🇸Saint Louis, Missouri, United States
Oklahoma Allergy & Asthma Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
Maimonides Medical Center, Division of Pediatric Pulmonology
🇺🇸Brooklyn, New York, United States
Allergy and Respiratory Center
🇺🇸Canton, Ohio, United States
Asthma Allergy & Pulmonary Associates
🇺🇸Philadelphia, Pennsylvania, United States
Allergy & Asthma Center of NC, PA
🇺🇸High Point, North Carolina, United States
Baker Allergy Asthma and Dermatology Research Center, LLC
🇺🇸Lake Oswego, Oregon, United States
Lynchburg Pulmonary Associates
🇺🇸Lynchburg, Virginia, United States
Asthma Inc.
🇺🇸Seattle, Washington, United States
Pulmonary and Research Associates
🇺🇸Spokane, Washington, United States
Integrity Research, LLC
🇺🇸Pensacola, Florida, United States
Sneeze, Wheeze and Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Georgia Pollens Clinical Research Centers, Inc
🇺🇸Albany, Georgia, United States
California Allergy & Asthma Medical Group
🇺🇸Palmdale, California, United States
Allergy & Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Alan Kaufman, MD
🇺🇸Bronx, New York, United States
Virginia Adult and Pediatric Allergy and Asthma PC
🇺🇸Richmond, Virginia, United States