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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
Asthma diagnosed by a medical specialist and/or history of positive methacholine rest and/or reversibility of >10% of FEV1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

AIR Trial 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.Check my eligibility
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.See study design
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.

AIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with asthma by a specialist.

AIR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma
Secondary outcome measures
Asthma Control Test
Asthma Quality of Life Questionnaire
Gastrointestinal tolerance of a Medium Chain Triglyceride additive to a normal diet in Asthmatics
+1 more

AIR Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: 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 II: Whole Lung Allergen ChallengeActive Control1 Intervention
patients with or without asthma will be given controlled doses of specified allergens
Group III: 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 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

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,015 Total Patients Enrolled
8 Trials studying Asthma
2,223 Patients Enrolled for Asthma
Serpil Erzurum, MDPrincipal Investigator - The Cleveland Clinic
Cleveland Clinic Hospital
Northeastern Ohio Universities College Of Medicine (Medical School)
Baylor College Of Medicine (Residency)
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Alternate Day Diet Clinical Trial Eligibility Overview. Trial Name: NCT01536522 — Phase < 1
Asthma Research Study Groups: Standard American Diet, Alternate Day Diet, Whole Lung Allergen Challenge, Nutritional Approach for Asthma
Asthma Clinical Trial 2023: Alternate Day Diet Highlights & Side Effects. Trial Name: NCT01536522 — Phase < 1
Alternate Day Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT01536522 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrolment opportunities for this research initiative?

"The information on clinicaltrials.gov indicates that this medical study is no longer actively recruiting participants for their trial, which was originally made public back in January 1st 2011 and most recently updated July 19th 2022. Nevertheless, there are 669 other studies currently looking to enlist patients."

Answered by AI

Is my profile compatible with this research initiative?

"This trial is searching for 60 patient volunteers aged 18 to 75 who suffer from asthma."

Answered by AI

Does this clinical research permit those aged 60 and above to participate?

"This clinical trial is open to participants aged 18-75. There are 142 trials catered towards those under the age of majority and 459 for seniors above 65."

Answered by AI
Recent research and studies
~1 spots leftby Jun 2024