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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00346398 |
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.
Condition | Intervention | Phase |
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Asthma Allergic Rhinitis |
Biological: Oral mucosal immunoprevention (OMIP) therapy Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease |
Estimated Enrollment: | 200 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Oral mucosal immunoprevention (OMIP) therapy
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2: Placebo Comparator |
Biological: Placebo
inactive form of experimental therapy containing no allergens
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Researchers suspect that allergies to common inhaled allergens (such as house dust mite, cat dander, and grass pollens) are a major cause of childhood asthma. Recent evidence suggests that if allergies to inhaled allergens are prevented, this can cause changes in the immune system that may inhibit the development of asthma. Although strategies to prevent allergies generally focus on avoiding the allergen, complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical.
Oral mucosal immunoprevention (OMIP) therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies. By exposing the patient to small, repeated, but increasing doses of the problem allergen over a long period of time, the patient's immune system is eventually desensitized to that particular allergen. OMIP therapy has been shown to be safe in children as young as 2 years old. This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease. Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema, allergic rhinitis, or asthma.
There are two groups in this study. Group 1 participants will receive OMIP therapy (a mixture of house dust mite, cat, and timothy grass allergens) as daily oral drops under the tongue for 1 year; Group 2 participants will receive placebo. Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects how their immune systems respond to allergens. There will be 5 study visits in the first year and 6 visits over the next 3 years. At all visits, participants will be assessed for allergy/asthma symptoms, will be asked to complete questionnaires, and may be asked to provide blood or saliva samples.
Ages Eligible for Study: | 18 Months to 30 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
Australia, Victoria | |
Royal Children's Hospital | |
Melbourne, Victoria, Australia, 3052 | |
Australia, Western Australia | |
Telethon Institute for Child Health Research | |
Perth, Western Australia, Australia, 6008 | |
Germany | |
Charite - Universitatsmedizin Berlin, CVK | |
Berlin, Germany | |
Sweden | |
Allergy Centre - Karolinska Institute | |
Stockholm, Sweden |
Principal Investigator: | Patrick Holt, MD | Telethon Institute for Child Health Research |
Study Chair: | Peter Sly, MD | Telethon Institute for Child Health Research |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN025AD |
Study First Received: | June 27, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00346398 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; United States: Institutional Review Board; Australia: Human Research Ethics Committee |
vaccine asthma allergy allergies |
food allergies hay fever pollen childhood asthma |
Food Hypersensitivity Otorhinolaryngologic Diseases Asthma Rhinitis Fever Hypersensitivity Lung Diseases, Obstructive |
Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases Nose Diseases |