Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

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