Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

Study Overview
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Brief Summary
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To determine the effect of medical food on reducing asthma symptoms in asthmatic children.

Official Title
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Effect of Novel Medical Food on Reducing the Frequency and Severity of Asthma Symptoms and Airway Hyper-responsiveness in Children With Mild to Moderate Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: medical food with EPA and GLA, vitamins and minerals
* Other: medical food minus EPA and GLA, antioxidant vitamins/minerals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible. Each subject also has to have: Subject is off of controller therapy 4 wks preceding visit 1. Mild to moderate persistent asthma Methacholine responsiveness with an FEV1 PC20 Able to perform reproducible spirometry Verbal assent in addition to consent History of prior clinical varicella or varicella vaccine. Nonsmoker in past year. Exclusion Criteria: Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period. Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit 2. Two or more hospitalizations for asthma in the past year. Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month. Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1 Subject is receiving one or more of the following medications: Astemizole prior to 3 months of visit 1 Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1 Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1. Theophylline prior to 4 weeks of visit 1 Subject with active upper respiratory tract infection prior to 4 weeks before visit 1 Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects. Subject has known hypersensitivity to any of the ingredients Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas Cystic fibrosis or any other chronic lung disease other than asthma. Subject having gastroesophogeal reflux undergoing medical treatment Significant medical illness other than asthma that could require oral corticosteroids during the study. Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen Subject has received IV globulins or immunosuppressants. Subject is known to be human immunodeficiency virus (HIV) positive. Pregnancy or lactation. If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method. Subject is morbidly obese

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: novel nutritional formula<br> | Other: medical food with EPA and GLA, vitamins and minerals<br>* 1 8oz serving per day for 12 weeks<br>|
| Active Comparator: Control nutritional product<br>1 8oz serving per day for 12 weeks | Other: medical food minus EPA and GLA, antioxidant vitamins/minerals<br>* 1 8oz serving a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma free days |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of airway hyper-responsiveness |  | 12 weeks | 
| time to the first asthma exacerbation |  | 12 weeks | 
| respiratory function (spirometry) |  | 12 weeks | 
| need for rescue for exacerbations of asthma symptoms. |  | 12 weeks |