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

NCT ID: NCT00567476

Last Updated: 2011-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-04-30

Brief Summary

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

Conditions

Asthma

Keywords

Asthma, anti-immunoglobulin E, omalizumab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: 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)

Intervention Type: DRUG

Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent

Long-acting beta 2-adrenergic agonist (LABA)

Intervention Type: DRUG

Fixed dose of LABA as prescribed prior to study entry

Short-acting beta 2-adrenergic agonist (SABA)

Intervention Type: DRUG

Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

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.

Group Type: ACTIVE_COMPARATOR

Inhaled corticosteroids (ICS)

Intervention Type: DRUG

Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent

Long-acting beta 2-adrenergic agonist (LABA)

Intervention Type: DRUG

Fixed dose of LABA as prescribed prior to study entry

Short-acting beta 2-adrenergic agonist (SABA)

Intervention Type: DRUG

Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

Interventions

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.

Intervention Type: DRUG

Inhaled corticosteroids (ICS)

Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent

Intervention Type: DRUG

Long-acting beta 2-adrenergic agonist (LABA)

Fixed dose of LABA as prescribed prior to study entry

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Xolair; salbutamol; terbutaline

Eligibility Criteria

Inclusion Criteria

• 12 to 75 years-old during screening visit.
• Body weight > 20 kg and < 150 kg.
• Daily or persistent asthma symptoms.
• Night symptoms at least once a week.
• Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal value and continuing asthma symptoms.
• FEV1 increased > 12% from baseline within 30 minutes of inhaled (up to 400 mcg) or nebulized (up to 5 mg) salbutamol.
• Subject taking more than 500 mcg/day of fluticasone or equivalent associated to a long-acting β2-agonist.
• Inhaled corticosteroid and long-acting beta-2 adrenergic agonist (LABA) doses that remained fixed during the last 12 weeks prior to screening.
• Medical history of at least two episodes of asthma exacerbation treated with systemic corticoid or at least one severe asthma exacerbation treated with systemic corticoid and hospitalization or emergency room visit in the last 12 months prior to screening.
• Positive skin prick test (diameter of wheal > 3mm) to at least one perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to which the subject was likely to be exposed during the study.
• Subject capable to read and understand asthma related quality of life questionnaire (Juniper's questionnaire).

Exclusion Criteria

• Pregnant, nursing female subjects.
• Female subjects without current acceptable contraceptive method.
• Previous history of allergy or hypersensitivity to omalizumab.
• Subjects with prior treatment with omalizumab.
• Subjects with medical history of psychiatric disorder.
• Subject had been treated with systemic corticosteroid for any reason other than asthma.
• Subject took β2 antagonist medication in the last 3 months prior to screening visit.
• Subject took protocol prohibited medication prior to screening.
• Medical history of food or drug related severe anaphylactoid reactions.
• Medical history of antibiotics allergy. Patients were included if the antibiotics to which they were allergic to were to be avoided for the entire duration of the study.
• Asthma related to non-steroidal anti-inflammatory drug (NSAID).
• Treatment of exacerbation in the 4 weeks prior to randomization.
• Other active lung diseases.
• Medical history of others uncontrolled diseases 3 months prior randomization (eg, infections, coronary heart diseases and metabolic diseases).
• Any history of cancer.
• Abnormal electrocardiogram (ECG), laboratory exams (clinically significant abnormalities), and chest X-ray (CXR).
• Evidence or history of drug or alcohol abuse.
• Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to screening visit.
• Smokers or smoking history of > 10 pack-years.
• Subject that had been treated with investigational drugs over the past 30 days or during the course of the trial.
• Subject had elevated IgE levels for reasons other than allergy.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharma

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Novartis Investigator Site

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CIGE025ABR01

Identifier Type: -

Identifier Source: org_study_id