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Evaluation treatment with biologicals in severe asthma


- candidate number28011
- NTR NumberNTR6754
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2017
- Secondary IDsnWMO 245 
- Public TitleEvaluation treatment with biologicals in severe asthma
- Scientific TitleEvaluation treatment with biologicals in severe asthma
- ACRONYM
- hypothesisIn patients with severe asthma identification of patient characteristics, biomarkers and parameters can be helpful for response evaluation in treatment with biologicals.
- Healt Condition(s) or Problem(s) studiedSevere asthma, Biological
- Inclusion criteriaPatients with severe asthma treated with biologicals
- Exclusion criteria-
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jan-2025
- Target number of participants150
- InterventionsProspective evaluation of patients with severe asthma treated with biologicals.
- Primary outcomePatient characteristics / biomarkers as predictors of response in treatment with biologicals in severe asthma
- Secondary outcome- The relation between the most useful parameters in response evaluation and the different biologicals / patient characteristics.
- The time to respons; the most appropriate time for respons evaluation, relation with patient characteristics (early and late responders), differences between the biologicals and response parameters.
- The outcome of treatment with biologicals on medium and longterm in severe asthma.
- The effect of treatment with biologicals on ENT-symptoms; parameters as predictors of response.
- TimepointsThe study consist of a baseline visite, visit at 2 and 4 months, and follow-up during continuing biological treatment.
At baseline, 2, 4 months and continuing fase parameters as part of the clinical proces are registered: demographics and patient characteristics, prednisolone and inhaled corticosteroids doses, adverse events, questionnaires (ACQ, AQLQ, HCU, BORG-ENT symptoms), lungfunction (spirometry, FeNO), blood sampling (cel differentation, IgE, RAST).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. A. ten Brinke
- CONTACT for SCIENTIFIC QUERIESdr. A. ten Brinke
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Stichting Longgeneeskunde Fryslan
- PublicationsN/A
- Brief summaryA lot of patients with severe asthma are treated in severe asthma centres with biologicals and it is expected that the amount of these patients will increase. These patients are systematically evaluated at the onset of the treatment and at 2 and 4 months after starting. After 4 months most of the patients can be evaluated as a responder or non-responder and responders continue their treatment with a systematical follow-up. However, (non) responding is partly based on subjective judgement of the patient and clinician, and on the improvement of miscellaneous parameters. Yet, which patient characteristics are predictors of response and which parameters are the most useful for response evaluation is still unravelled. Likewise, there is a lack of knowledge about the variation in time to response between the patients. Finally, the registration studies of the biologicals showed a good effect after 6 months of treatment, but there are little data on longterm effects. So the optimal use of biologicals is still questioned. In this study we hope to unravel these questions and give answers for optimal treatment with biological in the daily practice.
- Main changes (audit trail)
- RECORD14-okt-2017 - 4-nov-2017


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