Phase 2
N=58
Allergy Immunotherapy for the Reduction of Asthma
Wheezing · Asthma · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01028560 ↗Enrolled (actual)
58
Serious AEs
26.0%
Results posted
May 2019
Primary outcome: Primary: Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months) — 21.95; 25.68; 27.72; 27.85 score on a scale — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Allergen extracts (subcutaneous injections) (Biological); Standard of care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months) |
21.95; 25.68; 27.72; 27.85; 31.40; 29.68 | 0.38 |
| SECONDARY Number of Newly Gained Allergic Sensitizations as Assessed by Serum Specific Immunoglobulin E (IgE) Testing |
12; 16 | 0.677 |
| SECONDARY Peripheral Blood T Regulatory Cells as a Percentage of CD4+ (Cluster of Differentiation 4) Cells |
4.87; 5.90; 5.09; 5.30; 5.26; 5.76 | 0.5460 |
| SECONDARY Incidence Rate of Systemic Corticosteroid Bursts (CSB) Per Child |
1.28; 1.55 | 0.289 |
Summary
In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.
Eligibility Criteria
Inclusion Criteria
- Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
- Positive skin tests or specific Immunoglobulin E (IgE) antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
- The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:
- Major criteria: History of atopic dermatitis and/or parental history of asthma.
- Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
Exclusion Criteria
- The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur).
- The child was born following 35 or less weeks of gestation.
- Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
- The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
- The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
- The child ever received immunotherapy.
- The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
- History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
Data sourced from ClinicalTrials.gov (NCT01028560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.