Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

• reduction of airway hyper-responsiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• time to the first asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• respiratory function (spirometry) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• need for rescue for exacerbations of asthma symptoms. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

To determine the effect of medical food on reducing asthma symptoms in asthmatic children.

• Other: medical food with EPA and GLA, vitamins and minerals
  1 8oz serving per day for 12 weeks
• Other: medical food minus EPA and GLA, antioxidant vitamins/minerals
  1 8oz serving a day for 12 weeks

• Experimental: novel nutritional formula
  Intervention: Other: medical food with EPA and GLA, vitamins and minerals
• Active Comparator: Control nutritional product
  1 8oz serving per day for 12 weeks
  Intervention: Other: medical food minus EPA and GLA, antioxidant vitamins/minerals

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