Airway Redox and Gender Determinants in Severe Asthma (SARP3)

This study is currently recruiting participants.
Verified February 2014 by The Cleveland Clinic
Sponsor:
Collaborators:
Case Western Reserve University
University of Virginia
Information provided by (Responsible Party):
Serpil Erzurum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01759186
First received: November 16, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Asthma Research Program

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Development of clinical testing procedures to assign metabolic asthma phenotypes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Gender influences on severe asthma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
None interventional

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.

  Eligibility

Ages Eligible for Study:   6 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients living in the greater Cleveland area, and in Virginia

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759186

Contacts
Contact: Emmea Mattox, BSHA 216-445-1756 cleggee@ccf.org
Contact: Laura Logan, RN 216-844-7927 Laura.Logan@UHhospital.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Emmea Mattox    216-445-1756      
Principal Investigator: Serpil Erzurum, MD         
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Laurie Logan    216-844-7927      
Principal Investigator: Benjamin Gaston, MD         
Sub-Investigator: James Chmiel, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Denise Thompson-Bhatt    434-924-6875      
Principal Investigator: Gerald Teague, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Michelle Rhea    804-828-0228      
Principal Investigator: Anne-Marie Irani, MD         
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
  More Information

No publications provided

Responsible Party: Serpil Erzurum, multiple Prinicipal Investigators [B Gaston, S. Erzurum, G. Teague], The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01759186     History of Changes
Other Study ID Numbers: 6185
Study First Received: November 16, 2012
Last Updated: February 4, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by The Cleveland Clinic:
Asthma
Biomakers
Phenotype

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

ClinicalTrials.gov processed this record on April 17, 2014