This trial is active, not recruiting.

Condition asthma
Sponsor The Cleveland Clinic
Collaborator Case Western Reserve University
Start date December 2012
End date June 2017
Trial size 300 participants
Trial identifier NCT01759186, 6185


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma
time frame: 5 years

Secondary Outcomes

Development of clinical testing procedures to assign metabolic asthma phenotypes
time frame: 5 years

Eligibility Criteria

Male or female participants from 6 years up to 80 years old.

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.

Additional Information

Official title Severe Asthma Research Program
Principal investigator Serpil C Erzurum, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.