Airway Redox and Gender Determinants in Severe Asthma
Running, not enrolling
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01759186
- Run by
- The Cleveland Clinic
- People needed
- 300
- Starts
- 2012-12-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 6 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects with asthma
- children age 6-17 years old (25% enrollment)
- adults 18 years and older (75% enrollment)
You may not qualify if…
- 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.
Where it is running
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Virginia — Charlottesville, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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