Airway Redox and Gender Determinants in Severe Asthma (SARP3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 28, 2014
Last verified: July 2014

November 16, 2012
July 28, 2014
December 2012
June 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01759186 on ClinicalTrials.gov Archive Site
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
Same as current
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.
Same as current
 
Airway Redox and Gender Determinants in Severe Asthma
Severe Asthma Research Program

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients living in the greater Cleveland area, and in Virginia

Asthma
Not Provided
None interventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2017
June 2017   (final data collection date for primary outcome measure)

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.
Both
6 Years to 80 Years
Yes
Contact: Emmea Mattox, BSHA 216-445-1756 cleggee@ccf.org
Contact: Laurie Logan, RN 216-844-7927 Laurie.Logan@UHhospital.org
United States
 
NCT01759186
6185
Yes
Serpil Erzurum, The Cleveland Clinic
The Cleveland Clinic
  • Case Western Reserve University
  • University of Virginia
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
The Cleveland Clinic
July 2014

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