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…
ID
Bron
Aandoening
COPD, Exacerbations, hospital, hyperinflation, dynamic, small airways, airway inflammation, Quality of Life, airway epithelial pro-inflammatory response, genome-wide gene-expression profile, epithelial response to steroids
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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)).
Achtergrond van het onderzoek
NA
Doel van het onderzoek
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.
Onderzoeksopzet
Day 1,2,3,4,5,6,7 discharge and day 42
Onderzoeksproduct en/of interventie
None
Publiek
H.A.M. Kerstjens
University Medical Center Groningen (UMCG),
Department of Respiratory Medicine
Postbox 30.001
Groningen 9700 RB
The Netherlands
+31 (0)50 3612357
h.a.m.kerstjens@int.umcg.nl
Wetenschappelijk
H.A.M. Kerstjens
University Medical Center Groningen (UMCG),
Department of Respiratory Medicine
Postbox 30.001
Groningen 9700 RB
The Netherlands
+31 (0)50 3612357
h.a.m.kerstjens@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Male or Female, 40 years or older
- Doctor¡¦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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4403 |
| NTR-old | NTR4600 |
| CCMO | NL46407.042.14 |
| OMON | NL-OMON40607 |