Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study

Asthma Clinical Trial

— GPAC  

Official title:

A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346398
• Other study ID #: DAIT ITN025AD
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2006
• Last updated: April 30, 2015
• Start date: May 2006
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Institutional Review BoardAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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 immunoprophylaxis (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. The experimental arm 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; Placebo arm participants will receive an allergen free placebo solution. Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune system's response 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 30 Months

Eligibility

Inclusion Criteria:

• Diagnosed with eczema (atopic dermatitis)

• Family history of eczema, allergic rhinitis, or asthma

• Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean

• Weigh at least 9.5 kg (20.9 lbs)

• Parent or guardian willing to provide informed consent

Exclusion Criteria:

• Allergy to house dust mite, cat, or timothy grass

• Born prematurely (before 36th week's gestation)

• Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life

• Chronic pulmonary disease

• Chronic disease requiring therapy

• Past or current treatment with systemic immunomodulator medication

• Past or current treatment with allergen-specific immunotherapy

• Received 10 or more days of systemic steroids in the 3 months prior to study entry

• Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment

• Participated in another clinical study within the 3 months prior to study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Sensitization
• Asthma

Intervention

Biological:
• Oral mucosal immunoprophylaxis (OMIP)
OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.
• Placebo
The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Melbourne	Victoria
Australia	Telethon Institute for Child Health Research	Perth	Western Australia
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (2)

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. Review. — View Citation

Nelson HS. Advances in upper airway diseases and allergen immunotherapy. J Allergy Clin Immunol. 2006 May;117(5):1047-53. Epub 2006 Mar 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion	Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.; A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.; A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization.	Three years (36 months) after Treatment Completion	No
Secondary	Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion	Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.	Three years (36 months) after Treatment Completion	No
Secondary	Time to First Onset of Asthma	Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.	From Treatment Initiation to Month 36 Status Post Treatment Completion	No

External Links

•   Click here for the Immune Tolerance Network Web site
•   Immune Tolerance Network (ITN) TrialShare: open public access to participant-level data available for this trial