Functional Medicine in Asthma (FAst) Study
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 1, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- The Cleveland Clinic
- Interventions being studied
- Behavioral: Lifestyle Factors; Other: Customized use of Dietary Supplements; Other: Currently Accepted Asthma Care Guidelines
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The Cleveland Clinic FoundationCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 1, 2021. Always confirm current availability with the study team.