Clinical trial · Interventional
Functional Medicine in Asthma (FAst) Study
NCT02808689CI-TRIAL-00051023FAstcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Currently Accepted Asthma Care Guidelines | Other | — | UNRESOLVED |
| Customized use of Dietary Supplements | Other | — | UNRESOLVED |
| Lifestyle Factors | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Asthma Center
- description
- 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.
- interventionNames
- Other: Currently Accepted Asthma Care Guidelines
- type
- ACTIVE_COMPARATOR
- label
- Asthma Center plus Functional Medicine
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.