Characterization of Adults for Asthma Microbiome Research Studies
Characterization of Adults for Asthma Microbiome Research Studies
The purpose of this study is to characterize adult subjects regarding their history of
 allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may
 influence asthma severity and control. Assessments include baseline medical history, lung
 function tests, questionnaires, and collection of specimens for phenotypic characterization.
This is a prospective, observational, two-visit study in which approximately 200 subjects
 will be enrolled, including healthy controls, atopic controls without asthma, and patients
 with stable asthma (n = 150). Among asthmatics, 2/3 will be on regular inhaled corticosteroid
 therapy and 1/3 will not be taking inhaled corticosteroids. Subjects who meet study criteria
 will undergo phenotypic characterization in multiple domains, including evaluation of lung
 function, assessments of asthma/allergy history, asthma triggers, asthma symptom control,
 environmental microbial exposures and dietary intake. Oral rinse, sputum, stool, urine and
 blood specimens will be collected for microbiome-related analyses, including molecular and
 culture-based assays, metabolite studies, and to relate these to markers of inflammation and
 immune function. The overall goal is to enroll a cohort of well-characterized asthmatic and
 non-asthmatic control subjects to enable mechanism-oriented studies of how members of the
 airway microbiota and possibly also gut microbiota influence phenotypes of adult asthma.
1. For all subjects:

 Inclusion criteria:

 - Men/Women, ages 18-75, with or without current asthma, are eligible to be screened.

 Exclusion criteria:

 -  Cigarette smoking history of >30 total pack-years

 -  Current use of other smoked products or recreational drugs (e.g. pipes, cigars,
 e-cigarettes, other illicit drugs)

 -  History of lung disease other than asthma

 -  Recent upper respiratory tract infection treated with antibiotics within 8 weeks
 of visit 1

 -  Recent antibiotic use (except topical or ocular) within 8 weeks of visit 1
 (chronic antibiotic use for asthma management allowed)

 -  Currently pregnant or breast-feeding

 -  Other medical conditions or treatments that may increase subject risk or affect
 study results, based on study physician judgment. These include the following:
 significant cardiovascular disease(+/- active symptoms), arrhythmia, or stroke,
 active cancer, post-organ transplant

 -  Any other condition for which subject is taking immunosuppressive therapies
 (except steroids for asthma)

 -  History of allergy to albuterol or methacholine

 2. For asthma subjects only:

 Note: Enrollment target is for 90 asthmatics already taking inhaled corticosteroids
 prescribed by their physician (any formulation and dose) and 60 subjects who are not
 currently using inhaled corticosteroid.

 Additional inclusion criteria:

 -  History of asthma symptoms within the last 2 years (e.g. wheeze, shortness of
 breath, etc.)

 -  Evidence of stable asthma as assessed by initial screening

 -  No changes in asthma medications within 30 days of visit 1

 -  Methacholine PC20 (dose at which there is a 20 percent change) ≤ 8 mg/ml (for
 those asthmatics on inhaled steroids, PC20 ≤ 16 mg/ml), or change in FEV1 (forced
 expiratory volume in first second of spirometry effort)≥ 12% after 4 puffs of
 albuterol on reversibility testing (or PI discretion)

 -  If negative methacholine challenge or no evidence of bronchodilator
 reversibility, a strong history of physician-diagnosed/physician-managed asthma
 may allow for study inclusion, based on PI's judgement or discretion.

 -  Individuals with a history of physician-diagnosed asthma who have had
 bronchodilator reversibility testing or methacholine challenge performed within
 60 days of screening may be enrolled and these existing test results used in lieu
 of repeating the same test at visit 1 or visit 2.

 Additional exclusion criteria:

 -  An asthma exacerbation requiring treatment with oral or IV steroids within 1
 month of visit 1

 -  No asthma symptoms within the last 2 years

 3. For healthy control or atopic non-asthma subjects:

 Additional exclusion criteria:

 -  Evidence of abnormal lung function by any of the following: FEV1/FVC ratio <0.70, FEV1
 or FVC (forced vital capacity on spirometry) < 80% predicted, methacholine PC20 < 16
 mg/ml, or FEV1 improvement > 12% in response to albuterol

 -  Atopic non-asthma subjects found to have evidence of abnormal lung function, but
 without a clear or recent history of asthma, may be enrolled per PI's discretion.

 -  Possible pulmonary disease is identified by PI or Co-Is to explain an abnormal lung
 function result at the time of testing. The subject may be re-screened later at
 investigator's discretion.