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The effect of non-invasive ventilation on the systemic inflammatory response to exercise in COPD patients.


- candidate number6420
- NTR NumberNTR1991
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2009
- Secondary IDs2008/125 METC Radboud University Nijmegen
- Public TitleThe effect of non-invasive ventilation on the systemic inflammatory response to exercise in COPD patients.
- Scientific TitleThe effect of non-invasive ventilation on the systemic inflammatory response to exercise in COPD patients.
- ACRONYMN/A
- hypothesisNon-invasive ventilation reduces the inflammatory response to exercise.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Lung emphysema, Chronic bronchitis
- Inclusion criteriaCOPD patients.
- Exclusion criteria1. Long term oxygen therapy;
2. Respiratory insufficiency;
3. Asthma;
4. Exercise limiting disorders;
5. Exacerbation in last 6 weeks;
6. Smoking;
7. Oral corticosteroids;
8. Chronic inflammatory disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2010
- Target number of participants15
- InterventionsNon-invasive ventilation & sham ventilation.
- Primary outcomeSystemic inflammatory response.
- Secondary outcomeNone.
- Timepoints1. Rest;
2. After exercise;
3. 30 minutes after exercise.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES JDC Hannink
- CONTACT for SCIENTIFIC QUERIES JDC Hannink
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Nijmegen Medical Centre, Department of Pulmonary diseases
- PublicationsN/A
- Brief summaryThe effect of non-invasive ventilation during exercise on systemic inflammatory responses will be investigated in a double blind randomized placebo controlled (sham ventilation) cross-over design. During the first visit patients will cycle as long as possible, but maximally 20 minutes and during the second visit they will be asked to cycle exactly as long as during the first visit (isotime). Blood will be obtained at rest, at the end of the activity and 30 minutes afterwards to investigate markers of systemic inflammation.
- Main changes (audit trail)
- RECORD7-sep-2009 - 12-okt-2009


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