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

Sponsor
Novartis
Study ID
NCT00567476
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Nov 30, 2007
Status verified
Jun 2011
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
116 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omalizumab + Conventional Therapy
    Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
  • Active Comparator: Conventional Therapy
    Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

Primary Outcome Measure

The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Baseline and Week 20 ]

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