Asthma Inflammation Research

NCT01536522 | Enrolling By Invitation Early Phase 1 DMC FDA Drug

• 2 other identifiers: 10-1049PAR-09-185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergic Asthma; Non-allergic Asthma

Keywords

Asthma; Allergic Asthma; Non-allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics

  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 Outcomes (4)

• Improvement of lung function by spirometry testing

  24 weeks

• Asthma Quality of Life Questionnaire

  24 weeks

• Asthma Control Test

  24 weeks

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

  12

Study Arms (4)

Nutritional Approach for Asthma

ACTIVE COMPARATOR

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

Standard American Diet

PLACEBO COMPARATOR

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

Alternate Day Diet

ACTIVE COMPARATOR

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

Whole Lung Allergen Challenge

ACTIVE COMPARATOR

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

Biological: whole lung allergen challenge

Interventions

Nutritional approach for asthma DIETARY_SUPPLEMENT

participants will be provided a medium chain triglyceride supplement or placebo

Also known as: MCT supplement

Nutritional Approach for Asthma; Standard American Diet

Low Caloric Shake DIETARY_SUPPLEMENT

participants will be provided a low caloric dietary shake

Alternate Day Diet

whole lung allergen challenge BIOLOGICAL

inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation

Whole Lung Allergen Challenge

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (15)

• National Asthma Education and Prevention Program. National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics--2002. J Allergy Clin Immunol. 2002 Nov;110(5 Suppl):S141-219. No abstract available.

  PMID: 12542074 BACKGROUND

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• Dweik RA, Sorkness RL, Wenzel S, Hammel J, Curran-Everett D, Comhair SA, Bleecker E, Busse W, Calhoun WJ, Castro M, Chung KF, Israel E, Jarjour N, Moore W, Peters S, Teague G, Gaston B, Erzurum SC; National Heart, Lung, and Blood Institute Severe Asthma Research Program. Use of exhaled nitric oxide measurement to identify a reactive, at-risk phenotype among patients with asthma. Am J Respir Crit Care Med. 2010 May 15;181(10):1033-41. doi: 10.1164/rccm.200905-0695OC. Epub 2010 Feb 4.

  PMID: 20133930 BACKGROUND

• Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis. 1981 Jun;123(6):659-64. doi: 10.1164/arrd.1981.123.6.659.

  PMID: 7271065 BACKGROUND

• Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available.

  PMID: 7663792 BACKGROUND

• Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.

  PMID: 9872837 BACKGROUND

• Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.

  PMID: 1549827 BACKGROUND

• Dweik RA, Comhair SA, Gaston B, Thunnissen FB, Farver C, Thomassen MJ, Kavuru M, Hammel J, Abu-Soud HM, Erzurum SC. NO chemical events in the human airway during the immediate and late antigen-induced asthmatic response. Proc Natl Acad Sci U S A. 2001 Feb 27;98(5):2622-7. doi: 10.1073/pnas.051629498. Epub 2001 Feb 20.

  PMID: 11226289 BACKGROUND

• Dweik RA, Lewis M, Kavuru M, Buhrow L, Erzurum SC, Thomassen MJ. Inhaled corticosteroids and beta-agonists inhibit oxidant production by bronchoalveolar lavage cells from normal volunteers in vivo. Immunopharmacology. 1997 Oct;37(2-3):163-6. doi: 10.1016/s0162-3109(97)00043-x.

  PMID: 9403334 BACKGROUND

• Dweik RA, Mehta AC, Meeker DP, Arroliga AC. Analysis of the safety of bronchoscopy after recent acute myocardial infarction. Chest. 1996 Sep;110(3):825-8. doi: 10.1378/chest.110.3.825.

  PMID: 8797432 BACKGROUND

• Dweik RA, Stoller JK. Role of bronchoscopy in massive hemoptysis. Clin Chest Med. 1999 Mar;20(1):89-105. doi: 10.1016/s0272-5231(05)70129-5.

  PMID: 10205720 BACKGROUND

• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

  PMID: 15817806 BACKGROUND

• Khatri SB, Hammel J, Kavuru MS, Erzurum SC, Dweik RA. Temporal association of nitric oxide levels and airflow in asthma after whole lung allergen challenge. J Appl Physiol (1985). 2003 Jul;95(1):436-40; discussion 435. doi: 10.1152/japplphysiol.01127.2002. Epub 2003 Feb 7.

  PMID: 12576414 BACKGROUND

• Khatri SB, Ozkan M, McCarthy K, Laskowski D, Hammel J, Dweik RA, Erzurum SC. Alterations in exhaled gas profile during allergen-induced asthmatic response. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1844-8. doi: 10.1164/ajrccm.164.10.2106119.

  PMID: 11734434 BACKGROUND

• Wu W, Samoszuk MK, Comhair SA, Thomassen MJ, Farver CF, Dweik RA, Kavuru MS, Erzurum SC, Hazen SL. Eosinophils generate brominating oxidants in allergen-induced asthma. J Clin Invest. 2000 May;105(10):1455-63. doi: 10.1172/JCI9702.

  PMID: 10811853 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Serpil Erzurum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Lerner Research Institute

Model Details: feasibility and palatability of a food product for asthma

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 22, 2012
• Study Start: January 1, 2011
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)