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CompletedNCT01862523Updated Dec 5, 2014

Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

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

Phase
Phase 4
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Rhinitis

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03

In context

Rhinitis

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with persistent (> 52w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
  2. Age > 18 and \< 60 years
  3. Written informed consent
  4. Willingness to adhere to visit schedules
  5. Adequate contraceptive precautions in female patients with childbearing potential
  6. Unresponsiveness to nasal steroid spray (4 weeks of use)

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 and > 60 years
  2. Patients with AR, demonstrated by either positive skin prick test or RAST
  3. Asthma
  4. Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
  5. Systemic steroid treatment less than 4 weeks before the inclusion in the study.
  6. Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
  7. Inability of the patient to stop taking medication affecting nasal function.
  8. Evidence of infectious rhinitis/rhinosinusitis.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
39 participants (actual)

Study arms

  • Placebo comparator
    diluent

    diluent

    Biological: diluent

  • Experimental
    capsaicin

    capsaicin

    Biological: Capsaicin

  • No intervention
    control healthy volunteers

    control healthy volunteers

Interventions

  • BiologicalCapsaicin

    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)

  • Biologicaldiluent

    diluent

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • UZ Leuven
    Leuven, Vlaams-Brabant 8000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01862523
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
May 24, 2013
Start date
Feb 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 5, 2014

Study contacts

Laura Van Gerven, Doctor
principal investigator · UZ Leuven
Peter Hellings, Doctor
principal investigator · UZ Leuven

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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