Interleukin-5 Receptor Expression in COPD

NCT03984799 | Completed

• 1 other identifier: 21547
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• IL-5R expression on bronchial neutrophils

  IL-5R will be quantified on neutrophils purified from bronchoalveolar lavage fluid

  within 24 hours

• IL-5 concentration in BALF

  IL-5 will be quantified in bronchoalveolar lavage fluid

  within 24 hours

Study Arms (1)

Bronchoscopy

EXPERIMENTAL

Research bronchoscopy

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD

Also known as: Blood Draw

Bronchoscopy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 hypereosinophil syndrome (HES), eosinophilic granulomatous polyangiitis (EGPA), nasal polyposis, helminth infection, or any other medical condition associated with eosinophilia

Sponsors & Collaborators

• University of Virginia: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Borish L, Teague WG, Patrie JT, Wavell KW, Barros AJ, Malpass HC, Lawrence MG. Further evidence of a type 2 inflammatory signature in chronic obstructive pulmonary disease or emphysema. Ann Allergy Asthma Immunol. 2023 May;130(5):617-621.e1. doi: 10.1016/j.anai.2023.01.024. Epub 2023 Feb 2.

  PMID: 36736724 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bronchoscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: February 21, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)