Functional Medicine in Asthma (FAst) Study

Functional Medicine is a holistic approach to treating chronic conditions by attempting to
address the underlying causes of chronic disease states. The purpose is to address the whole
person, not just a set of symptoms. The patient care involves evaluating the interactions
among genetic, in-utero, and lifetime environmental exposures. In addition, Functional
Medicine specialists also aggressively address lifestyle factors such as nutrition and
exercise that influence long-term health and chronic diseases. By doing so, the intention is
to reduce ongoing biologic imbalances from deficiencies in dietary oxidants/antioxidants via
vitamin supplementation, hormonal imbalances through evaluation and management, and the need
for medications with unwarranted side effects that compound the chronic medical conditions
and adverse effects (e.g. excess use of antibiotics), and to systematically evaluate
intolerances to certain foods and additives.

Collaborating with Functional Medicine directly addresses the Guideline focus on control of
factors contributing to symptom exacerbation as well as the Cleveland Clinic care path
initiative goals of improving patient satisfaction with collaborative healthcare teams to
modify risk factors and counsel on environmental/lifestyle modifications. This study will
look at the effectiveness of adding a Functional Medicine approach to patient asthma care.

The investigators intention with this pilot study is to study subjective areas of medicine
(symptoms and quality of life) as objectively as possible, in order to supplement asthma care
guidelines with potential evidence of asthma-related quality of life, lung function/asthma
control, and biomarker-based reduction of inflammation and improvement of immune status.
Certainly there is value to both approaches and the aspects that are valuable need to be
determined so that these two disciplines can have a more integrated approach moving forward
and benefit a larger population in innovative and scientifically proven ways.

Inclusion Criteria:

- Women and men with ages >18 and <65

- Nonsmokers or Former smokers quit >1 yr ago, with 15 pack-years or less history of
smoking

- Clinical history consistent with moderate to severe asthma

- Measures of airflow obstruction and reactivity consistent with asthma (12% BD response
and/or positive methacholine challenge test) historically or at initial/screening
visit FEV1 between 40-100% predicted post bronchodilator

- Uncontrolled Asthma categorized ACT ≤19 (i.e. Not well controlled ACT= 16-19, Very
Poorly Controlled ACT ≤ 15)

- Willing to be seen in Asthma Center and willing to consider Functional Medicine
approach as an add-on to Asthma Center care

- Able to attend study visits as outlined in protocol.

Exclusion Criteria:

- Current smoker

- Life threatening asthma defined as 2 or more intubations for asthma in last 12 months

- Major psychiatric disturbance

- Any disorder, including but not limited to gastrointestinal, renal, neurological,
infectious, endocrine, metabolic or other physical impairment, that is not stable in
the opinion of the investigator

- Clinically important pulmonary disease other than asthma, including but not limited to
COPD, pulmonary fibrosis, cystic fibrosis, bronchiectasis

- Pregnant or breastfeeding

- Controlled asthma defined by stability and by ACT >19 and physician discretion for 2-3
months

- Current asthma exacerbations, (exacerbations are defined by urgent visit for asthma,
hospitalization or ICU stay for asthma, 3 days in succession of doubling use of SABA
or need for systemic steroids if not on systemic steroids, or increase of systemic
steroids if normally on systemic steroid) (patient can be rescreened 4 weeks after
exacerbation has resolved)

- Stable lung function, reduction in no more than 20% (or clinically significant per
patient) reduction of pulmonary function testing from time of stability

- History of being seen or had intervention/care based upon evaluation in Functional
Medicine Institute or following Functional Medicine principles/ approach to asthma
care.