|- candidate number||17767|
|- NTR Number||NTR4600|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mei-2014|
|- Secondary IDs||NL46407.042.14 ABR Nummer / UMCG|
|- Public Title||Gevangen lucht tijdens een longaanval|
|- Scientific Title||Hyperinflatie tijdens ziekenhuis exacerbaties van COPD|
|- hypothesis||The main objective is to establish the strength of the relationship between improvements in dyspnea and health related Quality of Life (HR-QoL) with the decrease in hyperinflation during the resolution of a COPD exacerbation in the hospital. The secondary objectives are to assess whether dynamic changes in airway inflammation and patency, especially in the small airways, contribute to changes in hyperinflation. Furthermore, whether the level and course of hyperinflation, airway epithelial pro-inflammatory response, epithelial response to steroids, genome-wide gene-expression profiles and the changes thereof, relate to quality of life and to length of hospital stay in COPD patients requiring hospitalisation for an exacerbation.|
|- Healt Condition(s) or Problem(s) studied||COPD, Exacerbation, Quality of life|
|- Inclusion criteria||- Male or Female, 40 years or older |
- Doctorˇ¦s diagnosis of COPD
- Incompletely reversible airflow obstruction defined as: 1) a post-bronchodilator FEV1/FVC < 70% and 2) FEV1 < 80% predicted. If patients have no readily available lung function measurement at admittance, but do have a clear doctors diagnosis of COPD, it is allowable to take the day 42 measurements of lung function.
- Experiencing an exacerbation of COPD requiring hospitalization at the moment of inclusion. An exacerbation is defined as a worsening of respiratory symptoms from the stable state and beyond normal day-to-day variations, which requires additional treatment.
- Patients must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch
- Written informed consent
|- Exclusion criteria||- Pneumonia, confirmed with X ray |
- COPD exacerbation requiring (non) invasive ventilation or admittance to an intensive care unit.
- Patient who received any investigational new drug within the last 4 weeks prior to admission or twice the duration of the biological half-life of any investigational new drug (whichever is longer).
Unstable angina pectoris or other clinically important cardiac co-morbidity requiring admission to a cardiology ward.
If any of these criteria were absent at admission, but occur during the course of the study, patients will be followed up within the protocol as much as possible.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||25-mei-2014|
|- planned closingdate||25-mei-2015|
|- Target number of participants||30|
|- Primary outcome||The changes in hyperinflation (as measured by inspiratory capacity) during resolution of the COPD exacerbation, and changes in HR-QoL (primary: CCQ) and dyspnea (Borg score)).|
|- Secondary outcome||Other HR-QoL and dyspnea patient report outcomes (PRO)'s|
Lung function parameters: dynamic hyperinflation, TLC, diffusion, FEV1, FVC, IOS, single breath nitrogen washout.
Enose for measurement of exhaled organic compounds.
Inflammation parameters measured by blood sample and nasopharyngeal swab.
Infection as assessed by routine lab and cultures.
Length of stay in the hospital
|- Timepoints||Day 1,2,3,4,5,6,7 discharge and day 42|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. H.A.M. Kerstjens|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.A.M. Kerstjens|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||17-mei-2014 - 17-okt-2015|