Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief Summary: To determine the effect of medical food on reducing asthma symptoms in asthmatic children.


Options:
A: 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
B: Inclusion Criteria:

* Diagnosed with asthma since at least 6 months prior to first visit
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
* At least one asthma exacerbation more than one but less than twelve months prior to first visit

Exclusion Criteria:

* Respiratory infection affecting asthma within 30 days before first visit
* Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
* Any significant disease or disorder that may jeopardize the safety of the patient

Additional inclusion and exclusion criteria will be evaluated by the Investigator.
C: Inclusion Criteria:

* Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
* Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria:

* Use of any b-blocking agent, including eye-drops.
* Use of oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
D: Inclusion Criteria:

* diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months

Exclusion Criteria:

* Regular need of \>4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years

Answer: A