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Enrolling by Invitation

NCT Number: NCT01536522

Asthma Inflammation Research

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional approach for asthma

Dietary Supplement

participants will be provided a medium chain triglyceride supplement or placebo

Other names: MCT supplement

Low Caloric Shake

Dietary Supplement

participants will be provided a low caloric dietary shake

whole lung allergen challenge

Biological

inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation

Primary outcomes

  1. Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics

    Time frame: 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 outcomes

  1. Improvement of lung function by spirometry testing

    Time frame: 24 weeks

    Quantitative data will be collected to evaluate any improvement mechanistically in the lungs using breathing tests

  2. Asthma Quality of Life Questionnaire

    Time frame: 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

  3. Asthma Control Test

    Time frame: 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

  4. Gastrointestinal tolerance of a Medium Chain Triglyceride additive to a normal diet in Asthmatics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: AIR

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2012
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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