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Nutritional Therapy for Asthma (AIR Trial)

Phase < 1

Waitlist Available

Led By Serpil Erzurum, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Current smoking or smoking history of greater than 10 pack-years

Diabetes (fasting blood sugar >110 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

This trial is looking to develop new diagnostic and prognostic tests for airway inflammation, as well as new targeted therapies, in order to improve the standard of care for asthma patients.

Who is the study for?

This trial is for people with asthma diagnosed by a specialist, who have had a positive methacholine test or significant improvement in lung function after treatment. Participants must be able to give informed consent and maintain a special diet. Smokers, those with coconut or milk allergies, diabetes, severe obesity, or serious heart/kidney diseases cannot join.

What is being tested?

The AIR program aims to improve asthma care by testing new treatments and tools for diagnosis and prognosis. This includes nutritional approaches like low-calorie shakes and whole lung allergen challenges to manage both non-allergic and allergic asthma.

What are the potential side effects?

Potential side effects may include reactions related to the dietary changes such as gastrointestinal discomfort due to the low caloric shake or increased inflammation from the whole lung allergen challenge.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently smoke or have smoked more than 10 pack-years.

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My fasting blood sugar is above 110 mg/dL.

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I do not have serious heart, lung, or kidney diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma

Secondary study objectives

Asthma Control Test

Asthma Quality of Life Questionnaire

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

+1 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Nutritional Approach for AsthmaActive Control1 Intervention

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

Group II: Whole Lung Allergen ChallengeActive Control1 Intervention

patients with or without asthma will be given controlled doses of specified allergens

Group III: Alternate Day DietActive Control1 Intervention

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

Group IV: Standard American DietPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met