CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 406 enrolled
Drug / intervention
Omalizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00264849
NCT00264849Phase 4Completed
CompareCT.gov

A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy

Novartis·interventional·Posted Dec 13, 2005·Updated Jun 29, 2018

In Brief

A Phase 4 clinical trial evaluating Omalizumab and Optimized asthma therapy for Asthma. Completed, enrolled 406 participants across 17 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Canada, Denmark, Germany, Greece, Hungary, Ireland, Israel, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
CollaboratorsGenentech, Inc., Tanox

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2005
Enrollment StartNov 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.6 years ago

Interventions

Omalizumabdrug

Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.

Optimized asthma therapyother

Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.