Airway Redox and Gender Determinants in Severe Asthma

Asthma Clinical Trial

— SARP3  

Official title:

Severe Asthma Research Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01759186
• Other study ID #: 6185
• Status: Active, not recruiting
• Start date: December 2012
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
The Cleveland Clinic	Case Western Reserve University, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender influences on severe asthma	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.	5 years
Primary	Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma	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	5 years
Secondary	Development of clinical testing procedures to assign metabolic asthma phenotypes	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	5 years