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OAT + Omalizumab for Asthma

Phase 4
Waitlist Available
Research Sponsored by Novartis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 16 and 32
Awards & highlights

Study Summary

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 16 and 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 16 and 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Secondary outcome measures
Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OAT + OmalizumabExperimental Treatment2 Interventions
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
Group II: Optimized Asthma Treatment (OAT)Active Control1 Intervention
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omalizumab
FDA approved

Find a Location

Who is running the clinical trial?

NovartisLead Sponsor
1,613 Previous Clinical Trials
2,720,862 Total Patients Enrolled
37 Trials studying Asthma
5,782 Patients Enrolled for Asthma
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,647 Total Patients Enrolled
50 Trials studying Asthma
21,106 Patients Enrolled for Asthma
TanoxIndustry Sponsor
6 Previous Clinical Trials
647 Total Patients Enrolled
3 Trials studying Asthma
490 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
2005. "Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00264849.
~21 spots leftby May 2025
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