COPD
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Age *40 years at recruitment. - Smoking history of *10 pack years. - COPD patients with an FEV1/FVC
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Patients with a history of asthma, significant bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease. - Patients taking immunosuppressive medications. - Active cancer diagnosis. - Long-term steroid therapy (*10 mg/day). - Females of childbearing potential without an efficient contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this prospective observational study is to determine the incidence of RSV acute respiratory infection or events leading to worsening cardiorespiratory status across multiple consecutive RSV. In addition, we will assess if and how the occurrence of an RSV virus infection affects the long-term outcome of COPD as reflected by rate of lung function decline, course of symptoms, and rate of COPD exacerbations during the follow-up of this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary objective, we will investigate whether it is possible to predict the long-term outcome of COPD, occurrence of COPD exacerbations and vulnerability to develop viral infections including RSV. To this end, we will analyse clinical data as well as markers of mucosal immunity and gene expression. The following parameters will be assessed: - Lung function (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%). - Daily PEF monitoring and symptoms recordings. - IOS measurements, R5, R10, R15, R20, R5-R20, Fres, X5, AX. - Multiple Breath Nitrogen Washout. - In- and expiratory HRCT scan will be performed at baseline. - PExA measurement will be performed at baseline. - Questionnaires (health status [CCQ and SGRQ] and CAT). - Blood transcriptomics for genetic susceptibility. - Blood RSV serology. - Blood cell differential counts. - Frozen whole blood. - Peripheral blood mononuclear cells for innate immune response. - Spontaneous sputum for viral RT-PCR, inflammatory cell counts, inflammatory cytokine release and bacteriology. - Nasopharyngeal swab for virus detection. | — |
Countries
Netherlands
Outcome results
None listed