UTMB Research on Severe Asthma (UROSA) Study

NCT02264691 | Completed

• 1 other identifier: 08-128
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

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

• William Calhoun, M.D.

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: March 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)