Airway Redox and Gender Determinants in Severe Asthma

NCT01759186 | Active Not Recruiting DMC

• 1 other identifier: 6185
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Asthma

Keywords

Asthma; Biomakers; Phenotype

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Development of clinical testing procedures to assign metabolic asthma phenotypes

  5 years

Other Outcomes (1)

• Gender influences on severe asthma

  5 years

Study Arms (1)

None interventional

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living in the greater Cleveland area, and in Virginia

You may qualify if:

• Subjects with asthma
• children age 6-17 years old (25% enrollment)
• adults 18 years and older (75% enrollment)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Case Western Reserve University: collaborator
• University of Virginia: collaborator

Study Sites (4)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 29400693 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Serpil C Erzurum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Benjamin Gaston, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• W. Gerald Teague, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: multiple Prinicipal Investigators [B Gaston, S. Erzurum, G. Teague]

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: January 3, 2013
• Study Start: December 1, 2012
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (4)