Asthma Inflammation Research (AIR)

May 24, 2026 updated by: Serpil Erzurum, The Cleveland Clinic

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional Approach for Asthma
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
participants will be provided a medium chain triglyceride supplement or placebo
Other Names:
  • MCT supplement
Placebo Comparator: Standard American Diet
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
participants will be provided a medium chain triglyceride supplement or placebo
Other Names:
  • MCT supplement
Active Comparator: Alternate Day Diet
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
participants will be provided a low caloric dietary shake
Active Comparator: Whole Lung Allergen Challenge
patients with or without asthma will be given controlled doses of specified allergens
Biological: whole 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
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
24 weeks
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
24 weeks
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.
12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Serpil Erzurum, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimated)

February 22, 2012

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1049
  • PAR-09-185 (Other Identifier: NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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