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

NCT00567476 | Completed Phase 4 Results

• 1 other identifier: CIGE025ABR01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma, anti-immunoglobulin E, omalizumab

Outcome Measures

Primary Outcomes (1)

• The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)

  The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.

  Baseline and Week 20

Secondary Outcomes (9)

• Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks

  Baseline and Week 20

• Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20

  Baseline and Week 20

• The Mean Change From Baseline to the End of Study in AQLQ Domain Score

  Baseline and Week 20

• Number of Asthma Exacerbation Episodes Per Participant

  From Baseline through 20 weeks

• Percentage of Participants Using Rescue Medication

  From Baseline through 20 Weeks

Study Arms (2)

Omalizumab + Conventional Therapy

ACTIVE COMPARATOR

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.

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

Conventional Therapy

ACTIVE COMPARATOR

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.

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

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.

Also known as: Xolair

Omalizumab + Conventional Therapy

Inhaled corticosteroids (ICS) DRUG

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

Conventional Therapy; Omalizumab + Conventional Therapy

Long-acting beta 2-adrenergic agonist (LABA) DRUG

Fixed dose of LABA as prescribed prior to study entry

Conventional Therapy; Omalizumab + Conventional Therapy

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.

Also known as: salbutamol, terbutaline

Conventional Therapy; Omalizumab + Conventional Therapy

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigator Site

São Paulo, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab; Albuterol; Terbutaline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharma

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 30, 2011
• Results First Posted: May 23, 2011

Record last verified: 2011-06

Locations

BR (1)