AsthmaNCT02566668
Immune Interactions in Severe Asthma
An observational study of Asthma, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- 1 year Observational Follow-up
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 22 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected using a Research Registry and clinic patients of the Investigators.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- 1 year Observational Follow-up
- Keywords
- Asthma, Severe Asthma, IL-10, IL-27, IL-13, Epithelial Cells, T lymphocytes, Interferon-g
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 year Observational Follow-upOther
Approximately 12 months after research bronchoscopy, subjects will return for follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic | 1 year observational follow-up Receives: Other: 1 year Observational Follow-up | |
| Non-Asthmatic | 1 year observational follow-up Receives: Other: 1 year Observational Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eotaxin-3 and IL-27 expression and their downstream signatures
Measure eotaxin-3 and IL-27 expression in bronchoalveolar lavage cells and epithelial cells.
Measured: 1 Year
Secondary outcomes (3)
Global gene expression in the airway epithelium and bronchoalveolar lavage cells using RNA-sequencing
Measured: 1 Year
Signal transducer and activator of transcription (STAT) signaling pathways
Pattern of activation and downstream responses
Measured: 1 Year
Targeted and untargeted gene expression as obtained from bronchoscopic samples
Compare with expression obtained from video assisted thoracoscopic (VATS) biopsies of systemic corticosteroid dependent patients.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion22 Sep 2022
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally E. Wenzel MD, University of Pittsburgh
- Investigators
- Sally E Wenzel, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566668
- Sponsor's protocol ID
- PRO15050456
- Status last verified
- Jan 2025
- First submitted
- 18 Sep 2015
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Airway-Epithelial Interactions in Steroid-Refractory Severe Asthma
- ClinicalTrials.gov ID
- NCT02566668
- Acronym / sponsor ID
- PRO15050456
- Conditions
- Asthma
- Keywords
- Asthma, Severe Asthma, IL-10, IL-27, IL-13, Epithelial Cells, T lymphocytes, Interferon-g
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic | – | Other: 1 year Observational Follow-up1 year observational follow-up |
| Non-Asthmatic | – | Other: 1 year Observational Follow-up1 year observational follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected using a Research Registry and clinic patients of the Investigators.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 year Observational Follow-upApproximately 12 months after research bronchoscopy, subjects will return for follow-up visit. | Other | Asthmatic, Non-Asthmatic |
Primary outcome
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.
3 secondary outcomes
Global gene expression in the airway epithelium and bronchoalveolar lavage cells using RNA-sequencing
Time frame: 1 Year
Signal transducer and activator of transcription (STAT) signaling pathways
Time frame: 1 Year
Targeted and untargeted gene expression as obtained from bronchoscopic samples
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally E Wenzel, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eotaxin-3 and IL-27 expression and their downstream signatures (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.