- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02566668
Immune Interactions in Severe Asthma
January 4, 2024 updated by: Sally E. Wenzel MD, University of Pittsburgh
Immune Airway-Epithelial Interactions in Steroid-Refractory Severe Asthma
This research study is being done to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma and people without asthma, at baseline and over time.
Individuals are being asked to join a research study to help understand the differences in the lungs and blood of participants with severe asthma compared to those with milder asthma and healthy individuals, as well as differences in overall health.
Investigators also want to determine whether these differences predict asthma-related and biologic outcomes over 1 year of follow up.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will obtain human lung samples by bronchoscopy from a range of asthmatics and healthy controls to address questions related to the mechanisms for the development of the complex immune processes observed in the lungs.
Samples will be evaluated for Type-1, Type-2 and Interleukin-27 (IL-27) expression (and their downstream signatures).
In addition, these samples will be evaluated for the presence or absence of Interleukin-10 (IL-10) as a counter regulatory pathway.
These pathways will be directly evaluated in epithelial brushings and bronchoalveolar lavage (BAL) cells, as well as BAL fluid.
Broad gene expression profiling (Ribonucleic acid (RNA)-sequencing) will also be performed to determine the range of immune-inflammatory markers present in these severe asthmatics.
Investigators will specifically address the Signal Transducers and Activators of Transcription (STAT) signaling pathways, particularly STAT-1 and STAT-3 to determine the pattern of activation and downstream responses to develop new therapies.
Additionally, in a subset, investigators will compare targeted and untargeted gene expression as obtained from bronchoscopic samples with expression obtained from clinically performed video assisted thoracoscopic (VATS) biopsies of very severe systemic corticosteroid dependent patients.
The ultimate goal of this studies is to determine whether a predictive biomarker panel can be identified in the less invasive bronchoscopic samples which predict the findings seen on VATS biopsy.
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Valerie McFarland
- Phone Number: 412-864-2218
- Email: mcfarlandvm@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Asthma Institute at UPMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects will be selected using a Research Registry and clinic patients of the Investigators.
Description
Inclusion Criteria:
- 18-65 years of age
- Non-smoker
- Asthmatic subjects must also demonstrate forced expiratory volume in 1 second (FEV1) bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤16 mg/mL (Historical methacholine data from previous National Institutes of Health (NIH) trial will be allowed)
Exclusion Criteria:
- Greater than 10 pack year smoking history (none in the last year)
- Vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder
- Other lung disease, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled.
Healthy Controls only: Pre-bronchodilator FEV1/Forced vital capacity (FVC) <0.70 or an improvement in FEV1 of more than 12% following 4 puffs of albuterol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Asthmatic
1 year observational follow-up
|
Approximately 12 months after research bronchoscopy, subjects will return for follow-up visit.
|
Non-Asthmatic
1 year observational follow-up
|
Approximately 12 months after research bronchoscopy, subjects will return for follow-up visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eotaxin-3 and IL-27 expression and their downstream signatures
Time Frame: 1 Year
|
Measure eotaxin-3 and IL-27 expression in bronchoalveolar lavage cells and epithelial cells.
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global gene expression in the airway epithelium and bronchoalveolar lavage cells using RNA-sequencing
Time Frame: 1 Year
|
1 Year
|
|
Signal transducer and activator of transcription (STAT) signaling pathways
Time Frame: 1 Year
|
Pattern of activation and downstream responses
|
1 Year
|
Targeted and untargeted gene expression as obtained from bronchoscopic samples
Time Frame: 1 Year
|
Compare with expression obtained from video assisted thoracoscopic (VATS) biopsies of systemic corticosteroid dependent patients.
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sally E Wenzel, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
September 18, 2015
First Submitted That Met QC Criteria
September 30, 2015
First Posted (Estimated)
October 2, 2015
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO15050456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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