Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone. The study comprised 4 phases: During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase. During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups. During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Subcutaneous injection dose according to the IgE level and body weight.
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
Formoterol 12ug tablets taken orally according to maximum daily dose.
Novartis Investigative Site
Tuxtla Gutiérrez, Chiapas, Mexico
Novartis Investigative Site
The Mean Prescribed Budesonide Dose (μg) at Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Time frame: Baseline
Number of Hospital Admissions Due to Asthma Exacerbation
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
Time frame: 12 month treatment duration
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
Time frame: 12 month treatment duration
Control of Asthma Symptoms- Daytime Symptoms
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Time frame: 12 month treatment duration
Control of Asthma Symptoms
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Time frame: 12 month treatment duration
Control of Asthma Symptoms- Rescue Medication Use
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Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
México, Edo. de México, Mexico
Novartis Investigative Site
Pachuca, Hidalgo, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadaljara, Jalisco, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
...and 11 more locations
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Time frame: 12 month treatment duration
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
Number of days of concomitant medications use reported by participants at all visits via diaries.
Time frame: 12 month treatment duration
Asthma Control Questionnaire (ACQ) at Baseline
The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (\> 95% of predicted) to 6 (\< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.
Time frame: Baseline
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ\[S\]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ\[S\]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.
Time frame: Baseline