NCT01759186Active, not recruiting
Airway Redox and Gender Determinants in Severe Asthma
Severe Asthma Research Program
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 16 Nov 2012
- Start date
- Dec 2012
- Primary completion date
- Aug 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Asthma
- NCT number
- NCT01759186
What you commit to
- Study type: Observational
- Planned participants: 300
- From Dec 2012 to the primary completion date, Aug 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- History of premature birth before 35 weeks gestation
Age
- 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
- Pregnancy during the characterization phase
- Current smoking
- Severe scoliosis or chest wall deformities
- Unwillingness to receive an intramuscular triamcinolone acetonide injection.
Who the study is looking for
- Subjects with asthma
- children age 6-17 years old (25% enrollment)
- adults 18 years and older (75% enrollment)
Age in the registry: 6 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Rainbow Babies and Children's Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.