Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
Completed
- Conditions
- Moderate to Severe Allergic Asthma
- Registration Number
- NCT01362621
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to \< 12 years of age, managed in a real-world setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
Inclusion Criteria
- Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
- Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
- Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
- Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). [e.g., A and (B or C)]
A. Fluticasone DPI > 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)
B. At least one of the following in the preceding 4 weeks prior to the screening visit:
- on average asthma symptoms > 2 days/week or multiple times in a day on ≤ 2 days/week
- nighttime awakenings ≥ 2 times/month due to asthma symptoms
- use of SABAs > 2 times/week on average
- some limitation in activity due to asthma
- on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best
C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
Exclusion Criteria
- Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
- Subjects with a history of prior use of omalizumab
- Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
- Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
- Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change from basline in Childhood Asthma Control Test 2 years The change from baseline in total Wasserfallen Clinical Symptom Score 2 years
- Secondary Outcome Measures
Name Time Method The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) 2 years The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) 2 years The number of days of missed school. 2 years The number of days of missed work. 2 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇵🇷San Juan, Puerto Rico