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Asthma Inflammation Research (AIR)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Serpil Erzurum, The Cleveland Clinic Identifier:
First received: February 13, 2012
Last updated: April 4, 2017
Last verified: April 2017

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 Intervention
Allergic Asthma
Non-allergic Asthma
Biological: Allergen
Dietary Supplement: low caloric shake

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Asthma Inflammation Research

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Mechanistic Outcomes related to biochemical and metabolic derangements [ Time Frame: A week to three months ]
    We are looking at oxidative mechanisms using biomarkers in urine and blood.

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alternate Day Diet
individuals will be provided a low caloric dietary shake to be consumed on alternate days but allowed to consume their regular diet on the non shake days
Dietary Supplement: low caloric shake
participants will be provided a low caloric dietary shake
Active Comparator: whole lung allergen challenge
individuals will be given controlled doses of specified allergen
Biological: Allergen
Inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation.

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Asthma is present
  • FEV1 is within acceptable limits
  • Informed Consent is present

Exclusion Criteria:

  • FEV1 is less than 35% predicted before, or less than 40% predicted after, bronchodilator administration.
  • Asthma is clinically unstable
  • Communication channel is not established for follow-up contacts
  • Clinically significant, unstable comorbidities are present
  • Additional exclusion criteria will be used for each specific test/procedure and will be listed under the risks for that procedure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01536522

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Serpil Erzurum, MD The Cleveland Clinic
  More Information


Responsible Party: Serpil Erzurum, Chair of the department of Pathobiology, PI, The Cleveland Clinic Identifier: NCT01536522     History of Changes
Other Study ID Numbers: 10-1049
PAR-09-185 ( Other Identifier: NIH )
Study First Received: February 13, 2012
Last Updated: April 4, 2017

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes processed this record on April 28, 2017