Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

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

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

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