Asthma
Conditions
Brief summary
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
Interventions
OTHERmedical food with EPA and GLA, vitamins and minerals
1 8oz serving per day for 12 weeks
OTHERmedical food minus EPA and GLA, antioxidant vitamins/minerals
1 8oz serving a day for 12 weeks
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| asthma free days | 12 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed