Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
- Conditions
- Severe persistent allergic asthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-003533-10-Outside-EU/EEA
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 123
•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).
Other protocol-defined inclusion criteria applied to the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
•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 exclusion criteria applied to the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ);Secondary Objective: 1.Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks <br>2.Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20 <br>3.The Mean Change From Baseline to the End of Study in AQLQ Domain Score <br>4.Number of Asthma Exacerbation Episodes Per Participant <br>5.Percentage of Participants Using Rescue Medication <br>6.Free Days With no Rescue Medication <br>7.Mean Number of Puffs of Rescue Medication Taken Per Day <br>8.Physician's Global Assessment of Treatment Effectiveness <br>9.Patient's Global Assessment of Treatment Effectiveness ;Primary end point(s): The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ);Timepoint(s) of evaluation of this end point: baseline and week 20
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks <br>2.Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20 <br>3.The Mean Change From Baseline to the End of Study in AQLQ Domain Score <br>4.Number of Asthma Exacerbation Episodes Per Participant <br>5.Percentage of Participants Using Rescue Medication <br>6.Free Days With no Rescue Medication <br>7.Mean Number of Puffs of Rescue Medication Taken Per Day <br>8.Physician's Global Assessment of Treatment Effectiveness <br>9.Patient's Global Assessment of Treatment Effectiveness ;Timepoint(s) of evaluation of this end point: - for secondary endpoinds 1, 2, and 3 as listed in E.5.2 - timepoints:<br>baseline and week 20<br>- for secondary endpoinds 4,5,6 and 7 as listed in E.5.2 - timepoints:<br>from baseline through week 20<br>- for secondary endpoinds 8 and 9 as listed in E.5.2 - timepoints: 20<br>weeks