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

This study has been completed.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00346398
First received: June 27, 2006
Last updated: June 4, 2014
Last verified: June 2014

June 27, 2006
June 4, 2014
May 2006
July 2011   (final data collection date for primary outcome measure)
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion [ Time Frame: Three years (36 months) after Treatment Completion ] [ Designated as safety issue: No ]

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.

  1. 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.
  2. 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.
Allergic sensitization in children at high risk of asthma and atopy
Complete list of historical versions of study NCT00346398 on ClinicalTrials.gov Archive Site
  • Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion [ Time Frame: Three years (36 months) after Treatment Completion ] [ Designated as safety issue: No ]
    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.
  • Time to First Onset of Asthma [ Time Frame: From Treatment Initiation to Month 36 Status Post Treatment Completion ] [ Designated as safety issue: No ]
    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.
  • Incidence of asthma in children at high risk for developing asthma and atopy
  • effects of OMIP on the immune response to allergens
Not Provided
Not Provided
 
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Asthma
  • Allergic Sensitization
  • Biological: Oral mucosal immunoprophylaxis (OMIP)
    Other Name: Allergen immunotherapy
  • Biological: Placebo
    Solution of: Glycerol, Sodium chloride, Disodium phosphate (dihydrate), Disodium dihydrogen phosphate (dihydrate), Sodium hydroxide and/or hydrochloric acid and water for injection
  • Experimental: Oral mucosal immunoprophylaxis (OMIP)
    Participants are administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. 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.
    Intervention: Biological: Oral mucosal immunoprophylaxis (OMIP)
  • Placebo Comparator: Placebo
    Participants are administered, via the same route as the experimental group, an oral placebo solution daily for 12 months. The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
12 Months to 30 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00346398
DAIT ITN025AD
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Principal Investigator: Patrick Holt, MD Telethon Institute for Child Health Research
Study Chair: Peter Sly, MD Telethon Institute for Child Health Research
National Institute of Allergy and Infectious Diseases (NIAID)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP