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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Lifestyle Factors Other: Customized use of Dietary Supplements Other: Currently Accepted Asthma Care Guidelines||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Asthma Center
Use of Currently Accepted Asthma Care Guidelines:
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.
- 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)
- Measurement of Airflow [ Time Frame: 9 Months ]Spirometry measures of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)
- Measurement of Airflow [ Time Frame: 9 Months ]Bronchodilator response, specific airway conductance (% SGaw) and specific airway resistance (SRaw)
- Daily Variability in Airflow [ Time Frame: 9 Months ]Peak flow measured twice daily and recorded in a diary
- Noninvasive Markers of Airway Inflammation [ Time Frame: 9 months ]Measurement of exhaled Nitric Oxide
- Quantity of Controller Medications Needed for Stability [ Time Frame: 9 months ]Total inhaled corticosteroid (ICS) dose
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
|Contact: Sumita Khatri, MD||216-445-1701|
|United States, Ohio|
|The Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Sumita Khatri, MD 216-445-1701 BARANJ2@ccf.org|
|Principal Investigator:||Sumita Khatri, MD||The Cleveland Clinic|