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Functional Medicine in Asthma (FAst) Study (FAst)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Factors
Customized use of Dietary Supplements
Currently Accepted Asthma Care Guidelines
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Moderate, Severe

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Asthma Center

Asthma Center plus Functional Medicine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Asthma Control
Measured by Asthma Control Test Questionnaire (ACQ)
Asthma Control
Measured by Asthma Quality of Life Questionnaire (AQLQ)

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2016
Last Updated
March 31, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02808689
Brief Title
Functional Medicine in Asthma (FAst) Study
Acronym
FAst
Official Title
Functional Medicine in Asthma (FAst) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Moderate, Severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma Center
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Asthma Center plus Functional Medicine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Factors
Intervention Description
Will look at nutrition and exercise that influence long-term health and chronic diseases.
Intervention Type
Other
Intervention Name(s)
Customized use of Dietary Supplements
Intervention Description
Reduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing.
Intervention Type
Other
Intervention Name(s)
Currently Accepted Asthma Care Guidelines
Intervention Description
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
Primary Outcome Measure Information:
Title
Asthma Control
Description
Measured by Asthma Control Test Questionnaire (ACQ)
Time Frame
9 Months
Title
Asthma Control
Description
Measured by Asthma Quality of Life Questionnaire (AQLQ)
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Measurement of Airflow
Description
Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)
Time Frame
9 Months
Title
Measurement of Airflow
Description
Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw)
Time Frame
9 Months
Title
Daily Variability in Airflow
Description
Peak flow measured twice daily and recorded in a diary
Time Frame
9 Months
Title
Noninvasive Markers of Airway Inflammation
Description
Measurement of exhaled Nitric Oxide
Time Frame
9 months
Title
Quantity of Controller Medications Needed for Stability
Description
Total inhaled corticosteroid (ICS) dose
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumita Khatri, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Medicine in Asthma (FAst) Study

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