The role of innate lymphoid cells in COPD and rhinovirus-induced COPD exacerbations

Completed

Conditions: COPD virus-induced exacerbation
10006436

Registration Number: NL-OMON45207

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

For rhinovirus challenges, patients
* non-smoking, or ex-smoking (*1 years ago), *10 pack years; GOLD stage II (post bronchodilator FEV1 <80% predicted and FEV1/FVC <70%)
* Allowed COPD specific medication: LABA and LAMA medication will be allowed, but no ICS
* Have no history of bronchiectasis, lung cancer or other significant respiratory disease.
* Be stable on COPD medication, no exacerbation or changes in COPD medication in the past 6 weeks. ;The age- and smoking history-matched controls will be extensively characterized with respect to lung function, medication and medical history. They have to:
* Be non-smoking, or ex-smoking (*1 years ago)
* Have no respiratory diagnosis of asthma or COPD
* Have no history of bronchiectasis, lung cancer or other significant respiratory disease.;For the COPD patients not challenged with rhinovirus:
* non-smoking, or ex-smoking (*2 years ago), GOLD I, II, IV
* no history of bronchiectasis, lung cancer or other significant respiratory disease;Non-COPD control group, not challenged with rhinovirus:
* Be non-smoking, or ex-smoking (*2 years ago), apart from those belonging to the controls who smoke
* Have no respiratory diagnosis of asthma or COPD

Exclusion Criteria

For rhinovirus challenges,
* Women who are pregnant, lactating or have a positive urine pregnancy test at visit 1
* RV16 titre > 1:6 in serum, measured at visit 1
* Has had any acute illness, including a common cold, within 4 weeks prior to visit 1
* Close contact with young children (< 2 years)
* Has donated blood or has had a blood loss of more than 450 mL within 60 days prior to screening visit 1 or plans to donate blood during the study;For the patients not challenged with rhinovirus:
* Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1<br /><br>1. Investigate the effects of a RV16-induced exacerbation in COPD patients and<br /><br>healthy subjects on the proportion of the different pulmonary and peripheral<br /><br>blood ILC populations, as well as their activation and cytokine production.<br /><br>2. Determination of the differences in innate cytokine production between<br /><br>bronchial epithelial cells from these groups, at baseline and after<br /><br>experimental RV16 infection.<br /><br>3. Study the interaction between bronchial epithelial cells obtained before and<br /><br>after experimental RV16 infection and ILCs.<br /><br><br /><br>Part 2<br /><br>1. Determination of the different ILC populations in the lungs and peripheral<br /><br>blood of COPD patients, who differ with respect in COPD severity, and compare<br /><br>these to healthy controls without COPD/asthma.<br /><br>2. Study the interactions between ILCs and bronchial epithelial cells and other<br /><br>local cells.</p><br>

Secondary Outcome Measures