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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
Results First Received: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Asthma
Allergic Sensitization
Interventions: Biological: Oral mucosal immunoprophylaxis (OMIP)
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject recruitment occurred between June 2006 and July 2007 at 2 sites in Australia and 1 site in the United States

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At a screening visit, subjects underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All guardians provided written informed consent

Reporting Groups
  Description
OMIP With Timothy Grass, Cat and House Dust Mite Allergens Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted 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. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
Placebo Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.

Participant Flow:   Overall Study
    OMIP With Timothy Grass, Cat and House Dust Mite Allergens     Placebo  
STARTED     25     26  
COMPLETED     22     24  
NOT COMPLETED     3     2  
Lost to Follow-up                 3                 0  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OMIP With Timothy Grass, Cat and House Dust Mite Allergens Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted 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. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
Placebo Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
Total Total of all reporting groups

Baseline Measures
    OMIP With Timothy Grass, Cat and House Dust Mite Allergens     Placebo     Total  
Number of Participants  
[units: participants]
  25     26     51  
Age, Customized  
[units: participants]
     
Aged 12-17 Months     6     6     12  
Aged 18-23 Months     16     12     28  
Aged 24-30 Months     3     8     11  
Gender  
[units: participants]
     
Female     13     12     25  
Male     12     14     26  
Region of Enrollment  
[units: participants]
     
United States     4     4     8  
Australia     21     22     43  
Severity of Atopic Dermatitis (AD) Using SCORAD Index [1]
[units: Units on a Scale]
Mean ± Standard Deviation
  13.3  ± 8.5     11.4  ± 9.1     12.3  ± 8.8  
[1] Scoring of Atopic Dermatitis (SCORAD) disease-severity scale measures intensity of erythema, edema/papulation, oozing/crusts, excoriations, lichenification and dryness, each on a scale from 0-3 for a maximum total of 18 points. This score is multiplied by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 0-10 point pruritus visual analog scale (VAS) and a 0-10 point loss of sleep VAS. Summary: SCORAD (0-103)=extent (0-100)/5+intensity (0-18)x3.5 + pruritus and sleep (0-20).Interpretation: SCORAD (0 (no disease) to 103 (most severe)).



  Outcome Measures
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1.  Primary:   Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion   [ Time Frame: Three years (36 months) after Treatment Completion ]
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Measure Type Primary
Measure Title Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
Measure Description

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.
Time Frame Three years (36 months) after Treatment Completion  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat minus one participant in placebo group who had a sibling in trial

Reporting Groups
  Description
OMIP With Timothy Grass, Cat and House Dust Mite Allergens Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted 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. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
Placebo Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.

Measured Values
    OMIP With Timothy Grass, Cat and House Dust Mite Allergens     Placebo  
Number of Participants Analyzed  
[units: participants]
  25     25  
Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion  
[units: participants]
  22     19  


Statistical Analysis 1 for Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.28
Odds Ratio (OR) [4] 2.3
95% Confidence Interval ( 0.5 to 10.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Participants who drop out (have missing efficacy endpoints) are considered treatment failures.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion   [ Time Frame: Three years (36 months) after Treatment Completion ]

3.  Secondary:   Time to First Onset of Asthma   [ Time Frame: From Treatment Initiation to Month 36 Status Post Treatment Completion ]


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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One participant in the placebo group could not be included in intent-to-treat analyses because a sibling was also in the study


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