NCT00567476

Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Omalizumab	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.
DRUG	Inhaled corticosteroids (ICS)	Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent
DRUG	Long-acting beta 2-adrenergic agonist (LABA)	Fixed dose of LABA as prescribed prior to study entry
DRUG	Short-acting beta 2-adrenergic agonist (SABA)	Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-12-05
• Last updated: 2011-06-30
• Results posted: 2011-05-23

Locations

1 site across 1 country: Brazil