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出境医 / 临床实验 / Interleukin-5 Receptor Expression in COPD
Interleukin-5 Receptor Expression in COPD
Study Description
Brief Summary:
At visit one, after the subject has signed the consent form, subjects will answer questions and have maximum reversibility lung function test to determine if they are eligible to proceed with the study. Once the study team has proven that the subject is eligible to proceed the study team will collect a sputum sample and blood sample to study their cells. At visit two the subjects will undergo a research bronchoscopy at this point the study team will collect more samples including a BAL sample and another blood sample. Three follow up phone calls will be conducted after the procedure to ensure subject safety, the study team will record any symptoms that they are experiencing at that time. Throughout this study the samples will be analyzed to see if a larger subset of COPD patients could benefit from using the drug mepolizumab.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD | Procedure: Bronchoscopy | Not Applicable |
Detailed Description:
During this study the subjects will have a bronchoscopy where the study team will collect airway samples to see how the subjects express certain cells. The subjects will also have two blood draws to provide information on the number of inflammatory cells that are present in their blood. This will help the study team determine if mepolizumab might be able to be used in more patients with COPD. The use of mepolizumab in COPD subjects with elevated blood eosinophils has been proven effective. However, the cellular mechanisms in the COPD population are unknown, including the extent to which these subjects express IL-5 in their airway and whether eosinophils are the sole target. Through this study the study team plans to provide proof of concept that mepolizumab could target additional IL-5-expressing immune cells in the airway, including especially PMNs. The study team will also investigate additional feasible biomarkers that could be utilized to predict mepolizumab responsiveness in COPD. The study team is hoping to determine if COPD patients with elevated blood eosinophils will demonstrate increased concentrations of IL-5 in their bronchoalveolar lavage (BAL) fluid and increased expression in their BAL of CD125+ PMNs. To address this hypothesis, the following specific aims will be addressed: To define the expression of IL-5R on PMNs in COPD and to demonstrate elevated concentrations of IL-5 in BALF obtained from COPD subjects with blood eosinophils (≥300/µL).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 25 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Interleukin-5 Receptor Expression in COPD |
| Actual Study Start Date : | February 21, 2020 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Bronchoscopy
Research bronchoscopy
|
Procedure: Bronchoscopy
Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD
Other Name: Blood Draw
|
Outcome Measures
Primary Outcome Measures :
- IL-5R expression on bronchial neutrophils [ Time Frame: within 24 hours ]IL-5R will be quantified on neutrophils purified from bronchoalveolar lavage fluid
- IL-5 concentration in BALF [ Time Frame: within 24 hours ]IL-5 will be quantified in bronchoalveolar lavage fluid
Eligibility Criteria
| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
• Age ≥40 and ≤80.
- COPD according to ATS-ERS guidelines
- Current or former smokers (≥10 pack-years) / non-smokers without a history of asthma
- FEV1/FVC ratio 0.70 before and after bronchodilator
- FEV1 after bronchodilator ≥50% predicted and <80% predicted
- No recent exacerbation within 30 days of bronchoscopy
- No symptoms of recent symptomatic infection (change in sputum volume or color in the previous 30 days).
- Absolute eosinophil count >300/µL within one month of the research bronchoscopy.
Exclusion Criteria:
-
• Current diagnosis of asthma
- Non-smokers with a history of asthma
- Recent exacerbation within 30 days of bronchoscopy
- Major medical co-morbid or primary disorder including systemic disorders involving the heart, CNS, renal, and endocrine systems
- Positive pregnancy test at time of bronchoscopy in women of child-bearing years
- Recent change in COPD control regimen (within 60 days). Stable orally-dosed CCS will not be a contraindication to study as long as the dose was not changed within 60 days.
- Recent (with 1-year) administration of a biologic agent
- Presence of allergic sensitization (atopy) (if obtained) will not be considered an exclusion.
- Presence of hypereosinophil syndrome (HES), eosinophilic granulomatous polyangiitis (EGPA), nasal polyposis, helminth infection, or any other medical condition associated with eosinophilia
Contacts and Locations
Contacts
| Contact: Kristen Wavell | 4349246874 | KWW7D@hscmail.mcc.virginia.edu | |
| Contact: Larry Borish, MD | 4349245917 | lb4m@virginia.edu |
Locations
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Kristen Wavell 434-924-6874 KWW7D@hscmail.mcc.virginia.edu | |
| Contact: Larry Borish 14349245917 lb4m@virginia.edu | |
Sponsors and Collaborators
University of Virginia
GlaxoSmithKline
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||||
| First Posted Date ICMJE | June 13, 2019 | ||||||||
| Last Update Posted Date | May 11, 2020 | ||||||||
| Actual Study Start Date ICMJE | February 21, 2020 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Interleukin-5 Receptor Expression in COPD | ||||||||
| Official Title ICMJE | Interleukin-5 Receptor Expression in COPD | ||||||||
| Brief Summary | At visit one, after the subject has signed the consent form, subjects will answer questions and have maximum reversibility lung function test to determine if they are eligible to proceed with the study. Once the study team has proven that the subject is eligible to proceed the study team will collect a sputum sample and blood sample to study their cells. At visit two the subjects will undergo a research bronchoscopy at this point the study team will collect more samples including a BAL sample and another blood sample. Three follow up phone calls will be conducted after the procedure to ensure subject safety, the study team will record any symptoms that they are experiencing at that time. Throughout this study the samples will be analyzed to see if a larger subset of COPD patients could benefit from using the drug mepolizumab. | ||||||||
| Detailed Description | During this study the subjects will have a bronchoscopy where the study team will collect airway samples to see how the subjects express certain cells. The subjects will also have two blood draws to provide information on the number of inflammatory cells that are present in their blood. This will help the study team determine if mepolizumab might be able to be used in more patients with COPD. The use of mepolizumab in COPD subjects with elevated blood eosinophils has been proven effective. However, the cellular mechanisms in the COPD population are unknown, including the extent to which these subjects express IL-5 in their airway and whether eosinophils are the sole target. Through this study the study team plans to provide proof of concept that mepolizumab could target additional IL-5-expressing immune cells in the airway, including especially PMNs. The study team will also investigate additional feasible biomarkers that could be utilized to predict mepolizumab responsiveness in COPD. The study team is hoping to determine if COPD patients with elevated blood eosinophils will demonstrate increased concentrations of IL-5 in their bronchoalveolar lavage (BAL) fluid and increased expression in their BAL of CD125+ PMNs. To address this hypothesis, the following specific aims will be addressed: To define the expression of IL-5R on PMNs in COPD and to demonstrate elevated concentrations of IL-5 in BALF obtained from COPD subjects with blood eosinophils (≥300/µL). | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||||||
| Condition ICMJE | COPD | ||||||||
| Intervention ICMJE | Procedure: Bronchoscopy
Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD
Other Name: Blood Draw
|
||||||||
| Study Arms ICMJE | Experimental: Bronchoscopy
Research bronchoscopy
Intervention: Procedure: Bronchoscopy
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
25 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 2021 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03984799 | ||||||||
| Other Study ID Numbers ICMJE | 21547 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Larry Borish, MD, University of Virginia | ||||||||
| Study Sponsor ICMJE | University of Virginia | ||||||||
| Collaborators ICMJE | GlaxoSmithKline | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Virginia | ||||||||
| Verification Date | May 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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