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Asthma Inflammation Research (AIR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Serpil Erzurum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01536522
First received: February 13, 2012
Last updated: May 12, 2017
Last verified: May 2017
February 13, 2012
May 12, 2017
October 2011
June 2021   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01536522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Asthma Inflammation Research
Asthma Inflammation Research

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
  • Asthma
  • Allergic Asthma
  • Non-allergic Asthma
  • Biological: Allergen
    Inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation.
  • Dietary Supplement: low caloric shake
    participants will be provided a low caloric dietary shake
  • 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
    Intervention: Dietary Supplement: low caloric shake
  • Active Comparator: whole lung allergen challenge
    individuals will be given controlled doses of specified allergen
    Intervention: Biological: Allergen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2021
June 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01536522
10-1049
PAR-09-185 ( Other Identifier: NIH )
Yes
Not Provided
Not Provided
Not Provided
Serpil Erzurum, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Serpil Erzurum, MD The Cleveland Clinic
The Cleveland Clinic
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP