Functional Medicine in Asthma (FAst) Study

Asthma Clinical Trial

— FAst  

Official title:

Functional Medicine in Asthma (FAst) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808689
• Other study ID #: FAst
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2021

Study information

• Verified date: November 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Lifestyle Factors
Will look at nutrition and exercise that influence long-term health and chronic diseases.

Other:
• Customized use of Dietary Supplements
Reduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing.
• Currently Accepted Asthma Care Guidelines
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

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control	Measured by Asthma Control Test Questionnaire (ACQ)	9 Months
Primary	Asthma Control	Measured by Asthma Quality of Life Questionnaire (AQLQ)	9 Months
Secondary	Measurement of Airflow	Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)	9 Months
Secondary	Measurement of Airflow	Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw)	9 Months
Secondary	Daily Variability in Airflow	Peak flow measured twice daily and recorded in a diary	9 Months
Secondary	Noninvasive Markers of Airway Inflammation	Measurement of exhaled Nitric Oxide	9 months
Secondary	Quantity of Controller Medications Needed for Stability	Total inhaled corticosteroid (ICS) dose	9 months