Severe Asthma Research Program - University of Virginia

Asthma Clinical Trial

— SARP3  

Official title:

The Severe Asthma Research Program at University of Virginia - Airway Redox Biochemistry as a Determinant of Asthma Phenotype During Adolescence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01761058
• Other study ID #: 16400
• Secondary ID: 1U10HL109164-01
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2013
• Last updated: July 1, 2013
• Start date: December 2012
• Est. completion date: May 2017

Study information

• Verified date: July 2013
• Source: University of Virginia
• Contact: Donna L Wolf, PhD
• Phone: 434-982-4206
• Email: dlw9t[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Observational

Clinical Trial Summary

The overall goal of this proposal is to better understand the basis of airway remodeling in severe asthma and how remodeling changes overtime. The investigators propose to study a well characterized cohort of individuals with severe asthma using a multidisciplinary state-of-the-art-approach.

Description:

Through innovative metabolomics and redox biochemistry, methodologies that are a strength and unique to our collaborative efforts, the investigators identified clinically relevant phenotypes of asthma. The phenotypes are defined by biomarkers specific to underlying biochemical mechanistic abnormalities, including eosinophil-mediated oxidation, depletion of antioxidants and protective airway S-nitrosothiols, and airway acidification. Here,the investigators propose to study a new component that is informative for longitudinal assessment of severe asthma phenotypes: gender effects. The investigators reason that identification of the metabolic mechanism(s) underlying onset of severe asthma in young women during adolescence, and resolution of severe asthma in boys, will reveal fundamental pathophysiology of severe asthma. Importantly, we aim to develop clinical testing procedures to accurately assign metabolic asthma phenotypes; and to follow patients in each phenotype to uncover clinical longitudinal outcomes. At the conclusion of the project, we anticipate that we will have 1) developed clinically relevant tests to identify severe asthma phenotypes; 2) determined the longitudinal outcome of the phenotypes; and 3) identified the mechanisms underlying the preponderance of women in the severe asthma population. This application will focus on the development or clinically relevant metabolic tests to identify subphenotypes of adults and children with severe asthma and will lead to new targeted innovative treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

Physician diagnosis of asthma

• Age 6 years to 17 years old Evidence of historical reversibility, including either;

1. FEV1 bronchodilator reversibility greater than or equal to 12%, or

2. Airway hyperresponsivesness reflected by a methacholine PC20 less than or equal to 16 mg/ml.

Exclusion Criteria:

• Exclusion criteria include any of the following:

1. Pregnancy during the characterization phase*,

2. Current smoking,

3. 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),

4. 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 that affect lung function, or congenital disorders of the lungs or airways,

5. History of premature birth before 35 weeks gestation,

6. Unwillingness to receive an intramuscular triamcinolone acetonide injection.

7. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,

8. Planning to relocate from the clinical center area before study completion,

9. Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record, or

10. Currently participating in an investigational drug trial.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Case Western Reserve University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function	decline in lung function (FEV1) over 3 years	baseline and 3 years	No
Secondary	Asthma Control Questionnaire	change in score in ACQ. Subjects report having worst asthma symptoms.	baseline and 3 years	No
Secondary	Puberty Changes	Lung function will worsen in girls with severe asthma at the time of menarche and the decline will be greater in women with severe asthma than men. And fewer girls than boys will outgrow severe asthma during puberty	baseline and 3 years	No
Secondary	Exacerbation	Exacerbation requiring systemic steroids	baseline and 3 years	No

External Links

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