Functional Medicine in Asthma (FAst) Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot, proof of concept, early stage study. The study goal is to determine whether the Functional Medicine approach to the treatment of moderate to severe persistent asthma enhances standard guideline-based care with respect to asthma outcomes.

Detailed Description
-----------------
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.

Official Title
-----------------
Functional Medicine in Asthma (FAst) Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Factors
* Other: Customized use of Dietary Supplements
* Other: Currently Accepted Asthma Care Guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Asthma Center<br>Use of Currently Accepted Asthma Care Guidelines: Assessment and monitoring: the use of objective measures of lung function to assess severity of asthma and to monitor the course of therapy, Control of factors contributing to symptom exacerbation: environmental control measures to avoid or eliminate factors that precipitate asthma symptoms or exacerbations, Pharmacotherapy: comprehensive pharmacologic therapy for long-term management, and Education for partnership in care: patient education that fosters a partnership among the patient, his/her family, and clinicians. | Other: Currently Accepted Asthma Care Guidelines<br>* Use of asthma care guidelines set forth by the National Institutes of Health/National Heart, Lung and Blood Institute (NIH/NHLBI) and Global Initiative for Asthma<br>|
| Active Comparator: Asthma Center plus Functional Medicine<br>All the factors in the Asthma Center Arm plus: Address lifestyle factors such as nutrition and exercise that influence long-term health and chronic diseases. 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. | Behavioral: Lifestyle Factors<br>* Will look at nutrition and exercise that influence long-term health and chronic diseases.<br>Other: Customized use of Dietary Supplements<br>* Reduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control | Measured by Asthma Control Test Questionnaire (ACQ) | 9 Months | 
| Asthma Control | Measured by Asthma Quality of Life Questionnaire (AQLQ) | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Airflow | Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) | 9 Months | 
| Measurement of Airflow | Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw) | 9 Months | 
| Daily Variability in Airflow | Peak flow measured twice daily and recorded in a diary | 9 Months | 
| Noninvasive Markers of Airway Inflammation | Measurement of exhaled Nitric Oxide | 9 months | 
| Quantity of Controller Medications Needed for Stability | Total inhaled corticosteroid (ICS) dose | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate, Severe