Role of ADAM 17 in epithelial dysregulation in COPD

Not yet recruiting

• Conditions: COPD; 10006436

• Registration Number: NL-OMON33267
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Age between 40 and 75 years
A medical indication to undergo a bronchoscopy;Inclusion criteria for healthy smokers:
• Individuals who currently smoke >= 10 cigarettes/day and > 10 packyears.
• Documented FEV1 > 80% predicted, FEV1/FVC > 70%.;Inclusion criteria for healthy never smokers:
•Individuals, who have not smoked during the at least last year, have never
smoked for as long as a year (i.e. at least one cigarette per day or one cigar per week, AND have < 0.5 packyear.
•Documented FEV1 > 80% predicted, FEV1/FVC > 70%.;Inclusion criteria for healthy ex-smokers:
• Individuals, who have not smoked during the last year, but who do have a smoking history with at least 10 packyears.
•Documented FEV1 > 80% predicted, FEV1/FVC > 70%.;inclusion criteria for smokers with COPD:
• > 10 packyears and current smoking.
• FEV1 < 80% predicted and FEV1/FVC < 70% of predicted.;inclusion criteria for ex- smokers with COPD:
• Age between 40-75 years.
• > 10 packyears. No smoking during the last year and a smoking history with at least 10 packyears.
• FEV1 < 80% predicted and FEV1/FVC < 70% of predicted.
• Referred by own physician for a bronchoscopy

Exclusion Criteria

Use of an anticoagulans (i.e. vitamin K antagonists) or the use of LMWh (low molecular weight heparin).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Decrease in the production of IL-8 in human bronchial epithelial cells after<br /><br>treatment with an ADAM inhibitor. Difference between patients with COPD and<br /><br>healthy controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•The production of inflammatory mediators (TGF-a, IL-8, MUC5AC) before and<br /><br>after stimulation (with cigarette smoke or PMA). Differences between patients<br /><br>with COPD and healthy controls (never-smokers, ex-smokers, and current smokers).<br /><br><br /><br>•Decrease in the PMA- or smoke-induced production of inflammatory mediators<br /><br>after treatment with a selective or nonselective ADAM inhibitor. Differences<br /><br>between COPD and healthy controls (never-smokers, ex-smokers, and current<br /><br>smokers).</p><br>