A Phase 4 interventional study of Capsaicin and diluent in Rhinitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-05.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact mechanisms involved in this treatment. Therefore, this study aims to address this issue by studying the functional (electrophysiologic) changes after specific stimulations in IR patients and healthy controls before and after capsaicin/placebo treatment.
As an essential step towards the improvement of the treatment of IR we will investigate the neural mechanisms underlying the therapeutic action of capsaicin. In particular, we plan to evaluate the effects of capsaicin on the functional properties of the innervation of nasal mucosa by monitoring the trigeminal nerve activity using measurements of negative mucosa potentials (NMP). NMPs, will be evoked by chemical and thermal stimuli in IR patients and healthy controls. Considering the evidence suggesting a role of sensory C-fibers in the pathophysiology of IR, we will employ low concentrations of irritants that specifically activate receptors expressed in those fibers, i.e., capsaicin for TRPV1 and cinnamaldehyde and allyl-isothiocyanate (mustard oil) for TRPA1. The same stimulations will be performed immediately after capsaicin treatment, and after 4 weeks, 3 months and 6 months. This will allow for an objective assessment of the functionality of the C-fiber innervation before the treatment, during the phase of therapeutic response and during the period of recurrence of the IR symptoms. The results of the NMP measurements will be contrasted with the therapeutic response and with evaluations of nasal congestion, nasal sensitivity and the presence of neuro-mediators found in nasal biopsies. Importantly, the independent assessment of the NMP responses mediated by either TRPV1 or TRPA1 will allow determining the specific role of these nociceptors in the pathophysiology of IR, which, in turn, may help to design more specific and effective therapies.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 39 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
diluent
Biological: diluent
capsaicin
Biological: Capsaicin
control healthy volunteers
Thirty-three\* well-characterized IR patients will be recruited and screened for participation in this study with nasal capsaicin spray (0,1 mmol/l ) using the treatment regimen described by van Rijswijk et al. (1 x 5 applications in one day, with 1 hour between each application)
diluent
negative mucosa potentials
change in negative mucosa potentials (baseline vs 1, 3 and 6 months after treatment)by measurement of AUC, delay-time and amplitude
Time frame: baseline, 1, 3 and 6 months
visual analogue scale
change of visual analogue scale of the administered stimuli (baseline vs 1, 3 and 6 months after treatment)
Time frame: baseline, 1, 3 and 6 months
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven