Asthma Inflammation Research
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- The Cleveland Clinic
- Study ID
- NCT01536522
- Phase
- EARLY_PHASE1
- Status
- Enrolling By Invitation
Conditions
- Allergic Asthma
- Asthma
- Non-allergic Asthma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Nutritional approach for asthma — DIETARY_SUPPLEMENTparticipants will be provided a medium chain triglyceride supplement or placebo
- Low Caloric Shake — DIETARY_SUPPLEMENTparticipants will be provided a low caloric dietary shake
- whole lung allergen challenge — BIOLOGICALinhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation
Study Details
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.
Key Dates
- Start date
- Jan 31, 2011
- Status verified
- May 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Active Comparator: Nutritional Approach for Asthmaindividuals 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
- Placebo Comparator: Standard American Dietpatients 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
- Active Comparator: Alternate Day Dietpatients 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
- Active Comparator: Whole Lung Allergen Challengepatients with or without asthma will be given controlled doses of specified allergens
Primary Outcome Measure
Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics [ Time Frame: 24 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | - |
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