Clinical trial NCT00567476: Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
Official title: A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 116
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

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

Primary outcomes:
measure: The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Baseline and Week 20
Secondary outcomes:
measure: Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks
timeFrame: Baseline and Week 20
measure: Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20
timeFrame: Baseline and Week 20
measure: The Mean Change From Baseline to the End of Study in AQLQ Domain Score
timeFrame: Baseline and Week 20
measure: Number of Asthma Exacerbation Episodes Per Participant
timeFrame: From Baseline through 20 weeks
measure: Percentage of Participants Using Rescue Medication
timeFrame: From Baseline through 20 Weeks
measure: Free Days With no Rescue Medication
timeFrame: From Baseline through 20 weeks (140 days)
measure: Mean Number of Puffs of Rescue Medication Taken Per Day
timeFrame: From Baseline through 20 Weeks
measure: Physician's Global Assessment of Treatment Effectiveness
timeFrame: 20 Weeks
measure: Patient's Global Assessment of Treatment Effectiveness
timeFrame: 20 Weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma
role: STUDY_CHAIR
References: