CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 enrolled
Drug / intervention
Omalizumab +3 moredrug
Likely dose
Omalizumab 375 mgfrom 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/NCT00567476
NCT00567476Phase 4Completed
CompareCT.gov

A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Novartis·interventional·Posted Dec 5, 2007·Updated Jun 30, 2011

In Brief

A Phase 4 clinical trial evaluating Omalizumab, Inhaled corticosteroids (ICS), and 2 other interventions for Asthma. Completed, enrolled 116 participants across 1 site.

Detailed Summary

This study investigated asthma-related quality of life in Brazilian patients using omalizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2007
Enrollment StartNov 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.6 years ago

Interventions

Omalizumabdrug

Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.

Inhaled corticosteroids (ICS)drug

Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent

Long-acting beta 2-adrenergic agonist (LABA)drug

Fixed dose of LABA as prescribed prior to study entry

Short-acting beta 2-adrenergic agonist (SABA)drug

Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.