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
  Purpose

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
Asthma
Allergic Sensitization
Biological: Oral mucosal immunoprophylaxis (OMIP)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 51
Study Start Date: May 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Oral mucosal immunoprophylaxis (OMIP)
Other Name: Allergen immunotherapy
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.
Biological: Placebo
Solution of: Glycerol, Sodium chloride, Disodium phosphate (dihydrate), Disodium dihydrogen phosphate (dihydrate), Sodium hydroxide and/or hydrochloric acid and water for injection

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346398

Locations
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
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Investigators
Principal Investigator: Patrick Holt, MD Telethon Institute for Child Health Research
Study Chair: Peter Sly, MD Telethon Institute for Child Health Research
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00346398     History of Changes
Other Study ID Numbers: DAIT ITN025AD
Study First Received: June 27, 2006
Results First Received: August 29, 2013
Last Updated: June 4, 2014
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
asthma
allergen
allergic disease
allergen immunotherapy
allergic sensitization
atopic dermatitis
eczema
food allergy
oral mucosal immunoprophylaxis (OMIP)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014