Asthma Inflammation Research

Study Overview
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Brief Summary
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The overall goal of the Asthma Inflammation Research [AIR] Translational Program is to create an integrated multidisciplinary team for the focused purpose of development of diagnostic and prognostic tests informative for airway inflammation, and for the design of innovative, targeted biologic therapeutics. The overarching aims of the AIR program are to conceptualize, develop, and test the next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will allow us to improve the standard of asthma care.

Detailed Description
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More than 20 million Americans suffer from asthma, and nearly half of asthma sufferers do not have their asthma under control. Although commonly diagnosed using physiological measures of airflow and bronchial hyperreactivity, asthma pathophysiology is related to chronic inflammation of the airway. Current diagnostic evaluation and monitoring are inadequate for proposed practice guidelines. The most commonly used test for evaluation of asthma is the measurement of airflow obstruction by spirometry. The National Asthma Education Prevention Program (NAEPP) and Expert Panel Reports set forth grading of asthma severity based on the frequency of symptoms, airflow, and the need for inhaled beta-agonists. Practice guidelines outline that the goals of therapy for asthma are to: maintain normal activity with near normal parameters of lung function, prevent exacerbations that lead to tissue injury, and avoid medication toxicity. In order to facilitate these goals, NAEPP defines key components for management including disease monitoring and stepped care pharmacotherapy. Unfortunately, there is no optimal plan for monitoring inflammation, which causes us to fail in key components in management of asthma. Limited options for anti-inflammatory treatments to control asthma likewise often lead to substantial morbidities due to treatment with high doses of corticosteroids. Our AIR program plans to develop novel asthma monitoring tests and design targeted therapeutics, which altogether may reduce toxicities and improve the long-term health of patients. Impact on broad scientific advancement. Our cumulative studies provide fundamental information on the molecular mechanisms that contribute to unresolving and excessive inflammation that leads to tissue remodeling. This mechanistic knowledge is of broad scientific importance as nearly all chronic human diseases are defined by prolonged and active inflammation, with tissue destruction, and failed attempts at healing. Thus, our investigations will provide comprehensive knowledge and consequent translational deliverables that may be widely applicable as diagnostic strategies and therapies in other chronic inflammatory diseases.

Official Title
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Asthma Inflammation Research

Conditions
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Allergic Asthma, Non-allergic Asthma, Asthma

Intervention / Treatment
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* Dietary Supplement: Nutritional approach for asthma
* Dietary Supplement: Low Caloric Shake
* Biological: whole lung allergen challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma diagnosed by a medical specialist and/or history of positive methacholine rest and/or reversibility of >10% of FEV1 FEV1 is within acceptable limits Informed Consent is present Exclusion Criteria: Diabetes (fasting blood sugar >110 mg/dL) Any milk allergies Coconut allergies BMI >40 kg/m2, Inability to maintain diet intervention Current smoking or smoking history of greater than 10 pack-years Any other significant respiratory or cardiac disease or the presence of clinically important comorbidities, including, uncontrolled coronary artery disease, acute or and chronic renal failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: feasibility and palatability of a food product for asthma
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional Approach for Asthma<br>individuals will be provide a pre measured dose of medium chain triglyceride to consume along with their meals. They will be instructed to add the MCT to their meal 3 times per day | Dietary Supplement: Nutritional approach for asthma<br>* participants will be provided a medium chain triglyceride supplement or placebo<br>* Other names: MCT supplement;|
| Placebo Comparator: Standard American Diet<br>patients will consume their usual diet with a pre measured dose of canola oil in place of the medium chain triglyceride as a control group. They will be instructed to add the placebo dose to their meal 3 times a day | Dietary Supplement: Nutritional approach for asthma<br>* participants will be provided a medium chain triglyceride supplement or placebo<br>* Other names: MCT supplement;|
| Active Comparator: Alternate Day Diet<br>patients will consume a regular Standard American Diet for 4 weeks and then provided a regulated dosed quantity of low caloric value shakes. they will consume this on alternating days | Dietary Supplement: Low Caloric Shake<br>* participants will be provided a low caloric dietary shake<br>|
| Active Comparator: Whole Lung Allergen Challenge<br>patients with or without asthma will be given controlled doses of specified allergens | Biological: whole lung allergen challenge<br>* inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics | Tolerability of the MCT will be assessed by maintenance of use of MCT by 20% or more participants over the 3 months of the study. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of lung function by spirometry testing | Quantitative data will be collected to evaluate any improvement mechanistically in the lungs using breathing tests | 24 weeks | 
| Asthma Quality of Life Questionnaire | Asthma Quality of Life Questionnaire will be evaluated for any decrease in asthma symptoms by a 7 point scale. 7 is not impaired and 1 is severely impaired. The higher the total score will determine better quality of life | 24 weeks | 
| Asthma Control Test | Asthma control test will be used to score improvement in day to day activities using a 5 point lscale. A score of 1 equals all of the time and a score of 5 equals not at all. The score ranges of 5 (poorly controlled) to 25 (complete control). A total ACT score greater than 19 indicates asthma is well controlled | 24 weeks | 
| Gastrointestinal tolerance of a Medium Chain Triglyceride additive to a normal diet in Asthmatics | GI symptoms will be documented and data captured to measure tolerance via a 5 point scale. A score of 1 equals symptoms all of the time and 5 equals never. The greater the score indicates less or no GI symptoms. | 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Allergic Asthma, Non-allergic Asthma