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 ]

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 ]


  Serious Adverse Events
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Time Frame Start of study through three years post-treatment (up to four years total)
Additional Description This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003). One participant in the placebo group is included in adverse event reports, but excluded from further analysis.

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.

Serious Adverse Events
    OMIP With Timothy Grass, Cat and House Dust Mite Allergens     Placebo  
Total, serious adverse events      
# participants affected / at risk     8/25 (32.00%)     7/26 (26.92%)  
Ear and labyrinth disorders      
Conductive deafness † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     1  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Infections and infestations      
Acute tonsillitis † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Ear infection † 1    
# participants affected / at risk     0/25 (0.00%)     2/26 (7.69%)  
# events     0     2  
Gastroenteritis viral † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     1  
Tonsillitis † 1    
# participants affected / at risk     1/25 (4.00%)     1/26 (3.85%)  
# events     1     1  
Injury, poisoning and procedural complications      
Joint dislocation † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Skin laceration † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     1  
Tooth fracture † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     1  
Psychiatric disorders      
Breathing-related sleep disorder † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     2  
Bronchial hyperreactivity † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Sleep apnoea syndrome † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Tonsillar hypertrophy † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Wheezing † 1    
# participants affected / at risk     0/25 (0.00%)     1/26 (3.85%)  
# events     0     1  
Skin and subcutaneous tissue disorders      
Eczema † 1    
# participants affected / at risk     1/25 (4.00%)     0/26 (0.00%)  
# events     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.1




  Other Adverse Events


  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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