Clinical trial NCT01759186: Airway Redox and Gender Determinants in Severe Asthma
Official title: Severe Asthma Research Program
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Keywords: Asthma
Biomakers
Phenotype
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: University of Virginia
First posted: 2013-01-03
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in the greater Cleveland area, and in Virginia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify metabolic mechanism(s) and age dependent change in the epidemiology of asthma
timeFrame: 5 years
Secondary outcomes:
measure: Development of clinical testing procedures to assign metabolic asthma phenotypes
timeFrame: 5 years
Other outcomes:
measure: Gender influences on severe asthma
timeFrame: 5 years
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: The Cleveland Clinic
name: Serpil C Erzurum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Benjamin Gaston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: W. Gerald Teague, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.