drugset / Trial / NCT00346398
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
Phase 2
Completed
51 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
Timeline
- Start
- 2006-05
- Primary completion
- 2011-07
- Completion
- 2011-07
Outcome
Missed primary endpoint
registry OMIP With Timothy Grass, Cat and House Dust Mite Allergens vs Placebo; p = 0.28; Odds Ratio (OR) 2.3 (95% CI 0.5 to 10.5) NCT00346398 ↗
registry Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo NCT00346398 ↗
Publications
- Background Mascarell L, Van Overtvelt L, Moingeon P. Novel ways for immune intervention in immunotherapy: mucosal allergy vaccines. Immunol Allergy Clin North Am. 2006 May;26(2):283-306, vii-viii. doi: 10.1016/j.iac.2006.02.009.
- Background Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. doi: 10.1016/j.jaci.2005.12.1306. Epub 2006 Mar 6.
- Results Holt PG, Sly PD, Sampson HA, Robinson P, Loh R, Lowenstein H, Calatroni A, Sayre P. Prophylactic use of sublingual allergen immunotherapy in high-risk children: a pilot study. J Allergy Clin Immunol. 2013 Oct;132(4):991-3.e1. doi: 10.1016/j.jaci.2013.04.049. Epub 2013 Jun 12. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oral mucosal immunoprophylaxis (OMIP) | Unknown | 0.6 ml | Oral |