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

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ClinicalTrials.gov Identifier: NCT00870584
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : November 17, 2011
Last Update Posted : November 17, 2011
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Novartis ( 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

Condition or disease Intervention/treatment Phase
Persistent Allergic Asthma Drug: Omalizumab Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870584


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Sponsors and Collaborators
Novartis Pharmaceuticals
Genentech, Inc.
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00870584     History of Changes
Other Study ID Numbers: CIGE025AUS33
First Posted: March 27, 2009    Key Record Dates
Results First Posted: November 17, 2011
Last Update Posted: November 17, 2011
Last Verified: October 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma; asthma management; asthma impairment ; Xolair ; omalizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents