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:

* The general goal of patient selection is to enroll patients for whom asthma physicians might prescribe GERD treatment, but where there is uncertainty whether it might be effective.
* Age 18 or older
* Physician diagnosed asthma
* If amount of air expired in the first second during a forced expiratory maneuver (FEV1) is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 20% from post-diluent baseline (PC20). PC20 less than 16 mg/ml during Visit 1
* If FEV1 less than 70% and greater than or equal to 50% predicted normal pre-bronchodilator: demonstrate 12% reversibility during Visit 1 or within past 12 months
* Currently on stable dose of daily inhaled steroids for asthma control, i.e., inhaled corticosteroid equivalent to 400 ug/day of fluticasone44 or greater for 8 weeks or longer
* Poor asthma control: Either of the following; a score of 1.5 or greater on the Juniper Asthma Control Questionnaire; two or more episodes of asthma symptoms in the past 12 months with each episode requiring at least one of the following: an emergency department visit, unscheduled physician visit, prednisone course, hospitalization
* Non-smoker for 6 months or longer
* Less than 10 pack/year smoking history

Exclusion Criteria:

* Surgery: Previous anti-reflux or peptic ulcer surgery
* Pulmonary function: FEV1 less than 50% predicted normal pre-bronchodilator
* GERD Symptoms: Severe reflux constituting a clinical indication for treatment with a PPI or H2 blocker, typically two or more episodes per week of heartburn requiring antacids
* Other major chronic illnesses; conditions which in the judgment of the Study Physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 insulin dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, major neuropsychiatric disorder
* Medication use: Anti-reflux medication (proton pump inhibitors or H2 blockers) within 1 month Theophylline, azoles, iron, anti-coagulants, insulin (for Type I diabetes), digitalis, any investigative drugs within 1 month
* Drug allergy: Previous adverse effects from proton pump inhibitors or methacholine challenge
* Females of childbearing potential: Pregnant or lactating, unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal)
* Inability or unwillingness to provide consent
* Inability to perform baseline measurements
* Completion of less than 10 of the last 14 days of screening period diary entry
* Inability to be contacted by telephone
* Intention to move out of the area within 6 months
B: 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
C: Inclusion Criteria:

* Healthy women
* No previous history of cardiovascular disease or cancer
* No contraindications to aspirin or vitamin E
D: Inclusion Criteria:

* Ethnicity: All ethnic groups
* Body mass index (BMI) 18.5-39.9 kg/m2
* Suboptimally controlled asthma:
* Diagnosis of asthma on the current medical problem list
* Currently prescribed at least 1 medication for the treatment of asthma
* Physiological evidence of asthma with demonstrable reversibility of airway obstruction, or a specialist's confirmation of asthma diagnosis based on chart review
* Documented history of high asthma-related emergency and/or inpatient encounters or reliever medication usage
* Asthma Control Test: total score \<20 or item score \<3 for any of the first 4 questions regarding symptoms (3-6x/week or more), nighttime awakening (1x/week or more), interference with normal activity (at least some of the time), and rescue medication use for symptom relief (2-3x/week or more)
* Kaiser member for ≥1 year
* PCP approval of study screening
* Able and willing to enroll and provide written informed consent

Exclusion Criteria:

* Intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms \<2x/week and nocturnal symptoms \<2x/month and no use of long-term control medications)
* Primary diagnosis of COPD (emphysema or chronic bronchitis) on the current medical problem list or suggested by baseline spirometry and smoking history
* Previous diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained at screening
* Previous cardiovascular disease: e.g., coronary heart disease, cerebrovascular disease, peripheral vascular disease, heart failure, or aortic aneurysm
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years
* Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection
* Diagnosis of bipolar or psychotic disorder or hospitalization for psychological or emotional problems within the last 2 years
* Diagnosis of a terminal illness and/or in hospice care
* Fasting LDL cholesterol \>190 mg/dL, triglycerides \>500 mg/dl, fasting blood glucose \>125 mg/dl
* Significant liver enzyme abnormality as indicated by AST or ALT more than 2 times the upper limit of normal or a clinical diagnosis of hepatitis
* Renal insufficiency (GFR\<60 ml/min)
* Current use of insulin or oral hypoglycemic agents
* Use of oral corticosteroids \>5 days/month on average
* Current use of medications for treatment of psychosis or manic-depressive illness
* Current use of prescription or non-prescription weight-loss products or any dietary/herbal supplements and unwillingness to discontinue;
* Inability to speak, read, or understand English at the 6th-grade level or above
* Inability to perform pulmonary function tests by spirometry in a consistent manner
* DASH concordance index \>60%
* Unwillingness to modify current diet
* Current or planned participation in a structured program that overtly focuses on diet and nutrition
* Planning to undergo bariatric surgery during the study period
* Actively attempting to lose weight, or weight change \>15 lbs during prior 3 months
* Consumption of \>21 alcoholic drinks per week, or \>=6 drinks on one occasion twice or more per week, or alcoholism as determined by the Alcohol Use Disorders Identification Test
* Pregnant, lactating, or planning to become pregnant during the study period
* No longer a Kaiser patient or planning to transfer care out of Kaiser or to move out of the area during the study period
* Family/household member of another study participant or of a study staff member
* Enrolled or planning to enroll in another research study that would limit full participation in the study or confound the interpretation of the study's findings
* Investigator discretion for safety or protocol adherence reasons

Answer: B