COPD virus-induced exacerbation
Conditions
Interventions
In part 1 all participants will undergo a RV16 infection.
COPD
COPD exacerbation
rhinovirus
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For rhinovirus challenges, patients * non-smoking, or ex-smoking (*1 years ago), *10 pack years; GOLD stage II (post bronchodilator FEV1
Exclusion criteria
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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 1. Investigate the effects of a RV16-induced exacerbation in COPD patients and healthy subjects on the proportion of the different pulmonary and peripheral blood ILC populations, as well as their activation and cytokine production. 2. Determination of the differences in innate cytokine production between bronchial epithelial cells from these groups, at baseline and after experimental RV16 infection. 3. Study the interaction between bronchial epithelial cells obtained before and after experimental RV16 infection and ILCs. Part 2 1. Determination of the different ILC populations in the lungs and peripheral blood of COPD patients, who differ with respect in COPD severity, and compare these to healthy controls without COPD/asthma. 2. Study the interactions between ILCs and bronchial epithelial cells and other local cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 1. Difference in maximum drop in FEV1, change in baseline morning or evening FEV1 on days 1-14 after RV16 challenge after RV16 infection between healthy and COPD patients. 2. Effects on two questionnaires for COPD symptoms (http://www.catestonline.org/english/indexEN.htm and as described in Mallia P, et al. Experimental rhinovirus infection as a human model of chronic obstructive pulmonary disease exacerbation. Am J Respir Crit Care Med. 2011 Mar 15;183(6):734-42). 3. Other immunological parameters, such as BAL cellular influx (neutrophils, eosinophils, basophils, T cells, B cells, macrophages, NK cells) and inflammatory mediator production. 4. Assess if the different ILC populations in the lungs after RV16 challenge correlate with clinical parameters, such as the maximum drop in FEV1, change in baseline morning or evening FEV1 on days 1-14 after RV16 challenge, and questionnaires. 5. Assess oxidative stress and cyto-protective responses in sputum supernatant and sputum macrophages. Part 2 1. Asses T lymphocytes and NK cells in blood and lung tissue from patients and controls. | — |
Countries
The Netherlands
Outcome results
None listed