Airway Redox and Gender Determinants in Severe Asthma (SARP3)
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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 |
- 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
- 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
- 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 |
Patients living in the greater Cleveland area, and in Virginia
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| Contact: Emmea Mattox, BSHA | 216-445-1756 | cleggee@ccf.org |
| Contact: Laura Logan, RN | 216-844-7927 | Laura.Logan@UHhospital.org |
| 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 | |
| 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: | January 3, 2013 |
| 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 June 18, 2013