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SARP3: Airway Redox and Gender Determinants in Severe Asthma

Sponsor
The Cleveland Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01759186
Collaborator
Case Western Reserve University (Other), University of Virginia (Other)
300
Enrollment
4
Locations
140
Duration (Months)
75
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will study the biologic and chemical differences that cause the greater incidence, and severity of asthma in women as compared to men. Severe asthma affects boys more than girls, while severe asthma in adults is predominantly a disease of women. The investigators aim to identify the processes that occur in the body that are behind the onset of severe asthma in young women during the teenage years, and the resolution of severe asthma in boys. To further evaluate gender influences on asthma, asthmatic women at different stages of their menstrual cycle (period) will be also studied. The investigators aim to use biomarkers to develop testing procedures that will identify different types or characteristics of asthma in men and women; and to follow patients over time to uncover relevant clinical outcomes of biomarkers. The investigators anticipate that they will 1) develop clinically relevant tests to identify unique types or characteristics of asthma and severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and 3) identify the reasons for why adult women are affected more than men with severe asthma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This scientific site-specific project is part of a larger network of asthma studies, the Severe Asthma Research Program (SARP). The mission of SARP is to improve the understanding of severe asthma to develop better treatments.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Severe Asthma Research Program
    Study Start Date :
    Dec 1, 2012
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    None interventional

    Outcome Measures

    Primary Outcome Measures

    1. Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma [5 years]

      To determine if asthma severity is worsened in females with changes in estradiol that occur during puberty as measured by asthma control tests and lung functions

    Secondary Outcome Measures

    1. Development of clinical testing procedures to assign metabolic asthma phenotypes [5 years]

      To determine if urine and blood and exhaled metabolic biomarkers can predict asthma phenotypes and severity as measured by lung functions and asthma control tests

    Other Outcome Measures

    1. Gender influences on severe asthma [5 years]

      To determine if adult women have more severe asthma in relation to menstrual cycle as measured by lung functions and remodeling on biopsies of the airway.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Subjects with asthma

    • children age 6-17 years old (25% enrollment)

    • adults 18 years and older (75% enrollment)

    Exclusion Criteria:

    • Pregnancy during the characterization phase

    • Current smoking

    • Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year),

    • Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion)

    • Severe scoliosis or chest wall deformities

    • History of premature birth before 35 weeks gestation

    • Unwillingness to receive an intramuscular triamcinolone acetonide injection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106
    2 Cleveland Clinic Cleveland Ohio United States 44195
    3 University of Virginia Charlottesville Virginia United States 22908
    4 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • The Cleveland Clinic
    • Case Western Reserve University
    • University of Virginia

    Investigators

    • Principal Investigator: Serpil C Erzurum, MD, The Cleveland Clinic
    • Principal Investigator: Benjamin Gaston, MD, Case Western Reserve University
    • Principal Investigator: W. Gerald Teague, MD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Serpil Erzurum, multiple Prinicipal Investigators [B Gaston, S. Erzurum, G. Teague], The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT01759186
    Other Study ID Numbers:
    • 6185
    First Posted:
    Jan 3, 2013
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Serpil Erzurum, multiple Prinicipal Investigators [B Gaston, S. Erzurum, G. Teague], The Cleveland Clinic
    Asthma
    Biomakers
    Phenotype
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Aug 18, 2022