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NCT Number: NCT01759186

Airway Redox and Gender Determinants in Severe Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma

    Time frame: 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 outcomes

  1. Development of clinical testing procedures to assign metabolic asthma phenotypes

    Time frame: 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

Other outcomes

  1. Gender influences on severe asthma

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Case Western Reserve University
  • University of Virginia

Registry information

Official study title

Severe Asthma Research Program

Acronym: SARP3

Important dates

Study start
2012
Primary completion
2027
Study completion
2028
First posted
Jan 3, 2013
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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