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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567476
• Other study ID #: CIGE025ABR01
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2007
• Last updated: June 28, 2011
• Start date: November 2007
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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 ß2-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 ß2 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.
• Inhaled corticosteroids (ICS)
Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent
• Long-acting beta 2-adrenergic agonist (LABA)
Fixed dose of LABA as prescribed prior to study entry
• Short-acting beta 2-adrenergic agonist (SABA)
Home use of nebulized ?2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

Locations

Country	Name	City	State
Brazil	Novartis Investigator Site	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks	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 score 1.0 indicates severe impairment.	Baseline and Week 20	No
Secondary	Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20	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. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.	Baseline and Week 20	No
Secondary	The Mean Change From Baseline to the End of Study in AQLQ Domain Score	AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.; The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment.	Baseline and Week 20	No
Secondary	Number of Asthma Exacerbation Episodes Per Participant	For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.	From Baseline through 20 weeks	No
Secondary	Percentage of Participants Using Rescue Medication	When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.	From Baseline through 20 Weeks	Yes
Secondary	Free Days With no Rescue Medication	When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.	From Baseline through 20 weeks (140 days)	Yes
Secondary	Mean Number of Puffs of Rescue Medication Taken Per Day	When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.	From Baseline through 20 Weeks	No
Secondary	Physician's Global Assessment of Treatment Effectiveness	At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma	20 Weeks	No
Secondary	Patient's Global Assessment of Treatment Effectiveness	At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma	20 Weeks	No