MedTrace Logo

Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

NCT01912872 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-07-02

Study results available
· View outcomes & findings →

Summary

Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.

Conditions

  • Severe IgE-mediated Asthma

Interventions

DRUG

Omalizumab

Subcutaneous injection dose according to the IgE level and body weight.

DRUG

Budesonide

Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.

DRUG

Formoterol

Formoterol 12ug tablets taken orally according to maximum daily dose.

DRUG

Budesonide

Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

DRUG

Formoterol

Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-11
Primary Completion
2015-08-06
Completion
2016-01-08

Countries

  • Mexico

Study Locations

More Related Trials

Entities

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 NCT01912872 on ClinicalTrials.gov