UTMB Research on Severe Asthma (UROSA) Study (UROSA)

To identify and understand biologic aspects of severe asthma compared to subjects with mild to moderate asthma and subjects without asthma (normal or healthy volunteers).

Study Overview

• Status: Completed
• Conditions: Asthma

Detailed Description

It has been shown that severe asthma differs from milder asthma in its pathophysiology; in particular we are interested in examining why patients with severe asthma have disease that is resistant to corticosteroids. While we will be studying patients with severe asthma, we also need to study subjects to act as controls. To this end we will recruit subjects into the following groups: Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics.

Subjects between the ages of 18 and 65 will be enrolled in this study. We aim to recruit enough subjects such that 120 male and female participants (30 in each of the above groups) will complete the bronchoscopy.

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics

Description

Inclusion Criteria:

• All participants must be in good general health (with exception to asthma). • Normal controls / healthy volunteers (NC) subjects with no past history of asthma or other lung disease. To determine this, subjects must have an FEV1 equal to or greater than 80% of predicted value and have a normal FEV1/FVC ratio.

Asthma subjects Eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. Participants must either have historical evidence of reversibility of FEV1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a PC20 for methacholine < 8mg/ml.

• Mild Asthma with no Corticosteroids (MANC) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
• Mild to Moderate asthma (MMA) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the MANC group or long acting β2-agonists.
• Severe asthma (SA) will be defined according to the ATS criteria for Refractory Asthma (10)

Exclusion Criteria:

• Exclusion criteria apply for all subjects:

  • Current smoker, or former smoker with >10 pack years history or having quit within the past year
  • Asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
  • Pregnant or lactating female
  • Significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
  • Diagnosis of emphysema or other significant pulmonary disease
  • If, in the opinion of the PI (WJC) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal (healthy volunteers); No Research Intervention. Clinically indicated interventions only.
Mild Asthmatics; No Research Intervention. Clinically indicated interventions only.
Mild to Moderate Asthmatics; No Research Intervention. Clinically indicated interventions only.
Severe Asthmatics; No Research Intervention. Clinically indicated interventions only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate patients with severe asthma	To evaluate patients with severe asthma and to establish the mechanisms by which the lack of response to treatment may occur.	7 Years

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: William Calhoun, M.D., UTMB

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 08-128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No