Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes
Brief Summary: The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

1. Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.


Options:
A: Inclusion Criteria:

1. Age 18-80
2. Class II through IV asthma sufferers will be included (mild persistent; moderate persistent; severe persistent).
3. Ability to read and write at minimum fifth grade level
4. Willing to comply with study instructions and sign an informed consent
5. English-speaking

Exclusion Criteria:

1. Pregnancy or lactation
2. Concurrent serious or life-threatening illness as determined by clinical judgment
3. Psychiatric disorder as determined by clinical judgment.
4. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
5. Fish allergy or history of adverse reaction to vitamin C or fish oil as determined by clinical history.
B: 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
C: 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
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: A