Airway Redox and Gender Determinants in Severe Asthma

Status:	Active, not recruiting
Conditions:	Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	6 - 80
Updated:	7/22/2018
Start Date:	December 2012
End Date:	June 2019

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.

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.

We found this trial at

sites

Rainbow Babies and Children's Hospital

11100 Euclid Avenue
Cleveland, Ohio 44106

(216) 844-1000