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

Novartis

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Omalizumab; Drug: Inhaled corticosteroids (ICS); Drug: Long-acting beta 2-adrenergic agonist (LABA); Drug: Short-acting beta 2-adrenergic agonist (SABA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567476

CIGE025ABR01

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Omalizumab + Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Inhaled corticosteroids (ICS)

Drug: Short-acting beta 2-adrenergic agonist (SABA)

Drug: Long-acting beta 2-adrenergic agonist (LABA)

Drug: Omalizumab

Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Inhaled corticosteroids (ICS)

Drug: Short-acting beta 2-adrenergic agonist (SABA)

Drug: Long-acting beta 2-adrenergic agonist (LABA)