AsthmaFAstNCT02808689
Functional Medicine in Asthma (FAst) Study
A study testing Lifestyle Factors, Customized use of Dietary Supplements and Currently Accepted Asthma Care Guidelines in people with Asthma, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Lifestyle Factors, Customized use of Dietary Supplements and Currently Accepted Asthma Care Guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Lifestyle Factors, Customized use of Dietary Supplements, Currently Accepted Asthma Care Guidelines
- Keywords
- Moderate, Severe
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle FactorsBehavioural
Will look at nutrition and exercise that influence long-term health and chronic diseases.
Customized use of Dietary SupplementsOther
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 GuidelinesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Factors; Other: Customized use of Dietary Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control
Measured by Asthma Control Test Questionnaire (ACQ)
Measured: 9 Months
Asthma Control
Measured by Asthma Quality of Life Questionnaire (AQLQ)
Measured: 9 Months
Secondary outcomes (5)
Measurement of Airflow
Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)
Measured: 9 Months
Measurement of Airflow
Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw)
Measured: 9 Months
Daily Variability in Airflow
Peak flow measured twice daily and recorded in a diary
Measured: 9 Months
Noninvasive Markers of Airway Inflammation
Measurement of exhaled Nitric Oxide
Measured: 9 months
Quantity of Controller Medications Needed for Stability
Total inhaled corticosteroid (ICS) dose
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumita Khatri, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808689
- Sponsor's protocol ID
- FAst
- Acronym
- FAst
- Status last verified
- Nov 2020
- First submitted
- 16 Jun 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Medicine in Asthma (FAst) Study
- ClinicalTrials.gov ID
- NCT02808689
- Acronym / sponsor ID
- FAst / FAst
- Conditions
- Asthma
- Keywords
- Moderate, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Center | Active comparator | Other: Currently Accepted Asthma Care GuidelinesUse 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. |
| Asthma Center plus Functional Medicine | Active comparator | Behavioral: Lifestyle Factors, Other: Customized use of Dietary SupplementsAll 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle FactorsWill look at nutrition and exercise that influence long-term health and chronic diseases. | Behavioural | Asthma Center plus Functional Medicine |
| Customized use of Dietary SupplementsReduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing. | Other | Asthma Center plus Functional Medicine |
| Currently Accepted Asthma Care GuidelinesUse 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 | Other | Asthma Center |
Primary outcome
Asthma Control
Time frame: 9 Months
Measured by Asthma Control Test Questionnaire (ACQ)
Asthma Control
Time frame: 9 Months
Measured by Asthma Quality of Life Questionnaire (AQLQ)
5 secondary outcomes
Measurement of Airflow
Time frame: 9 Months
Measurement of Airflow
Time frame: 9 Months
Daily Variability in Airflow
Time frame: 9 Months
Noninvasive Markers of Airway Inflammation
Time frame: 9 months
Quantity of Controller Medications Needed for Stability
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumita Khatri, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Factors, Customized use of Dietary Supplements and Currently Accepted Asthma Care Guidelines in people with Asthma, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control (time frame: 9 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.