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Functional Medicine in Asthma (FAst) Study (FAst)

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ClinicalTrials.gov Identifier: NCT02808689
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Lifestyle Factors Other: Customized use of Dietary Supplements Other: Currently Accepted Asthma Care Guidelines Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Medicine in Asthma (FAst) Study
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Asthma Center

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
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

Active Comparator: Asthma Center plus Functional Medicine

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
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.




Primary Outcome Measures :
  1. Asthma Control [ Time Frame: 9 Months ]
    Measured by Asthma Control Test Questionnaire (ACQ)

  2. Asthma Control [ Time Frame: 9 Months ]
    Measured by Asthma Quality of Life Questionnaire (AQLQ)


Secondary Outcome Measures :
  1. Measurement of Airflow [ Time Frame: 9 Months ]
    Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)

  2. Measurement of Airflow [ Time Frame: 9 Months ]
    Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw)

  3. Daily Variability in Airflow [ Time Frame: 9 Months ]
    Peak flow measured twice daily and recorded in a diary

  4. Noninvasive Markers of Airway Inflammation [ Time Frame: 9 months ]
    Measurement of exhaled Nitric Oxide

  5. Quantity of Controller Medications Needed for Stability [ Time Frame: 9 months ]
    Total inhaled corticosteroid (ICS) dose



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808689


Contacts
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Contact: Sumita Khatri, MD 216-445-1701

Locations
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United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sumita Khatri, MD    216-445-1701    BARANJ2@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Sumita Khatri, MD The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02808689     History of Changes
Other Study ID Numbers: FAst
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Moderate
Severe

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases