Allergic Asthma, Asthma, Non-allergic Asthma
Conditions
Keywords
Asthma, Allergic Asthma, Non-allergic Asthma
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTNutritional approach for asthma
participants will be provided a medium chain triglyceride supplement or placebo
DIETARY_SUPPLEMENTLow Caloric Shake
participants will be provided a low caloric dietary shake
BIOLOGICALwhole lung allergen challenge
inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
feasibility and palatability of a food product for asthma
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of lung function by spirometry testing | 24 weeks | Quantitative data will be collected to evaluate any improvement mechanistically in the lungs using breathing tests |
| Asthma Quality of Life Questionnaire | 24 weeks | 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 |
| Asthma Control Test | 24 weeks | 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 |
| Gastrointestinal tolerance of a Medium Chain Triglyceride additive to a normal diet in Asthmatics | 12 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSerpil Erzurum, MD
The Cleveland Clinic
Outcome results
None listed