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Asthma Inflammation Research (AIR)

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ClinicalTrials.gov Identifier: NCT01536522
Recruitment Status : Recruiting
First Posted : February 22, 2012
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Serpil Erzurum, The Cleveland Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Allergic Asthma Non-allergic Asthma Dietary Supplement: Nutritional approach for asthma Dietary Supplement: Low Caloric Shake Biological: whole lung allergen challenge Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: feasibility and palatability of a food product for asthma
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Asthma Inflammation Research
Actual Study Start Date : January 2011
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536522


Contacts
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Contact: Michelle Koo, BS 216-445-6695 koom@ccf.org
Contact: Suzy Comhair, Ph.D 216-445-6686 comhais@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michelle Koo, BS    216-445-6695    koom@ccf.org   
Contact: Suzy Comhair, Ph.D    216-445-6686    comhais@ccf.org   
Sub-Investigator: Raed Dweik, MD         
Sub-Investigator: Mark Aronica, MD         
Sub-Investigator: Sumita Khatri, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Serpil Erzurum, MD The Cleveland Clinic

Publications:

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Responsible Party: Serpil Erzurum, Chair of Lerner Research Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01536522     History of Changes
Other Study ID Numbers: 10-1049
PAR-09-185 ( Other Identifier: NIH )
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Serpil Erzurum, The Cleveland Clinic:
Asthma
Allergic Asthma
Non-allergic Asthma

Additional relevant MeSH terms:
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Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes