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

October 12, 2011 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Jasper Summit Research, LLC
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Allergy Asthma and Immunology Center of Alaska
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
    • California
      • Encinitas, California, United States, 92024
        • Waren W. Pleskow, MD
      • Fresno, California, United States, 93720
        • William Ebbeling, MD, Inc
      • Huntington Beach, California, United States, 92647
        • Pediatric Care Medical Group, Inc
      • Palmdale, California, United States, 93551
        • California Allergy & Asthma Medical Group
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group, Inc
      • Santa Barbara, California, United States, 93110
        • Sansum Clinic
      • Walnut Creek, California, United States, 94598
        • Allergy & Asthma Clinical Research, Inc.
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida, Inc
      • Hialeah, Florida, United States, 33012
        • Palm Spring Research Institute, Inc
      • Pensacola, Florida, United States, 32514
        • Integrity Research, LLC
      • Sarasota, Florida, United States, 34233
        • Hugh Windom, MD, PA
      • South Miami, Florida, United States, 33143
        • South Miami Clinical Research, LLC
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers, Inc
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze and Itch Associates, LLC
      • Skokie, Illinois, United States, 60076
        • Chest Medicine Clinical Services
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Clinical Research Center of Indiana
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Allergy & Asthma Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Crescent Springs, Kentucky, United States, 41017
        • Abraham Research, PLLC
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Rx R&D
      • Opelousas, Louisiana, United States, 70570
        • Acadiana Medicine Clinic
    • Maine
      • Bangor, Maine, United States, 04401
        • Paul A Shapero, MD
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Chesapeake Clinical Research
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc.
    • New York
      • Bronx, New York, United States, 10465
        • Alan Kaufman, MD
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center, Division of Pediatric Pulmonology
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester Research Center
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Allergy & Asthma Center of NC, PA
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Medical Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Allergy and Respiratory Center
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma and Clinical Research Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Allergy & Asthma Clinic
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy Asthma and Dermatology Research Center, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Asthma Allergy & Pulmonary Associates
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • AAPRI Clinical Research Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Pediatric Pulmonary Associates of North Texas, PA
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research
      • Fort Worth, Texas, United States, 76132
        • North Texas Institute for Clinical Trials
      • Houston, Texas, United States, 77054
        • Allergy & Asthma Associates
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Pulmonary Associates
      • Richmond, Virginia, United States, 23229
        • Virginia Adult and Pediatric Allergy and Asthma PC
    • Washington
      • Seattle, Washington, United States, 98105
        • Asthma Inc.
      • Spokane, Washington, United States, 99204
        • Pulmonary and Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Xolair
Placebo Comparator: Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
Time Frame: 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.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025AUS33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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