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

NCT00567476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2011-06-30

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00567476 on ClinicalTrials.gov