Airway Redox and Gender Determinants in Severe Asthma

Severe Asthma Research Program

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01759186

Acronym

SARP3

Enrollment

300

Registered

2013-01-03

Start date

2012-12-01

Completion date

2028-08-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Biomakers, Phenotype

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma	5 years	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

Secondary

Measure	Time frame	Description
Development of clinical testing procedures to assign metabolic asthma phenotypes	5 years	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSerpil C Erzurum, MD

The Cleveland Clinic

PRINCIPAL_INVESTIGATORBenjamin Gaston, MD

Case Western Reserve University

PRINCIPAL_INVESTIGATORW. Gerald Teague, MD

University of Virginia

Outcome results