Allergic asthma
Conditions
Interventions
Trade Name: Xolair
Product Name: Omalizumab
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Current Spon
Sponsors
Novartis Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 239 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Primary Outcome Measures: •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 Objective: Secondary Outcome Measures: •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. ;Primary end point(s): Change from baseline in the total score of ACT;Timepoint(s) of evaluation of this end point: Time point was Visit 14 (Week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Investigator’s Global Evaluation of Treatment Effectiveness (IGETE), which was compared between treatment groups;Timepoint(s) of evaluation of this end point: At the end of study (Visit 14/Week 24) | — |
Countries
United States
Contacts
Public ContactClinical trial information desk
Novartis Pharma AG
Outcome results
None listed