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

Conditions

• Severe IgE-mediated Asthma

Eligibility Criteria

Sex

ALL

Age

6 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Subcutaneous injection dose according to the IgE level and body weight.
• Budesonide — DRUG
  Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
• Formoterol — DRUG
  Formoterol 12ug tablets taken orally according to maximum daily dose.
• Budesonide — DRUG
  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.
• Formoterol — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 11, 2013

Status verified

Jun 2019

Primary completion

Aug 6, 2015

Completion

Jan 8, 2016

Study Design

Enrollment

112 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab + budesonide and formoterol
  Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.
• Active Comparator: Budesonide and formoterol
  Participants will receive budesonide and formoterol according to maximum daily dose.

Primary Outcome Measure

The Mean Prescribed Budesonide Dose (μg) at Baseline [ Time Frame: Baseline ]