Functional Medicine in Asthma (FAst) Study

NCT02808689 | Completed DMC

• 1 other identifier: FAst
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Moderate; Severe

Outcome Measures

Primary Outcomes (2)

• Asthma Control

  Measured by Asthma Control Test Questionnaire (ACQ)

  9 Months

• Asthma Control

  Measured by Asthma Quality of Life Questionnaire (AQLQ)

  9 Months

Secondary Outcomes (5)

• Measurement of Airflow

  9 Months

• Measurement of Airflow

  9 Months

• Daily Variability in Airflow

  9 Months

• Noninvasive Markers of Airway Inflammation

  9 months

• Quantity of Controller Medications Needed for Stability

  9 months

Study Arms (2)

Asthma Center

ACTIVE COMPARATOR

Use of Currently Accepted Asthma Care Guidelines: 1. Assessment and monitoring: the use of objective measures of lung function to assess severity of asthma and to monitor the course of therapy, 2. Control of factors contributing to symptom exacerbation: environmental control measures to avoid or eliminate factors that precipitate asthma symptoms or exacerbations, 3. Pharmacotherapy: comprehensive pharmacologic therapy for long-term management, and 4. 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

Asthma Center plus Functional Medicine

ACTIVE COMPARATOR

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; Other: Customized use of Dietary Supplements

Interventions

Lifestyle Factors BEHAVIORAL

Will look at nutrition and exercise that influence long-term health and chronic diseases.

Asthma Center plus Functional Medicine

Customized use of Dietary Supplements OTHER

Reduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing.

Asthma Center plus Functional Medicine

Currently Accepted Asthma Care Guidelines OTHER

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

Asthma Center

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Sumita Khatri, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 22, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: February 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)