Asthma Inflammation Research (AIR)

This study is currently recruiting participants.
Verified February 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Serpil Erzurum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01536522
First received: February 13, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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
Asthma
Allergic Asthma
Non-allergic Asthma
Biological: Allergen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536522

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

Locations
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
Principal Investigator: Serpil Erzurum, MD The Cleveland Clinic
  More Information

Publications:

Responsible Party: Serpil Erzurum, Chair of the department of Pathobiology, PI, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01536522     History of Changes
Other Study ID Numbers: 10-1049, PAR-09-185
Study First Received: February 13, 2012
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 22, 2014