Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

Rhinitis Clinical Trial

Official title:

Unraveling the Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls by Measuring Mucosal Potentials in the Nose.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862523
• Other study ID #: mucosal potentials in the nose
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2012
• Last updated: December 4, 2014
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis

Intervention

Biological:
• Capsaicin
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
diluent

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, 1, 3 and 6 months	No
Secondary	visual analogue scale	change of visual analogue scale of the administered stimuli (baseline vs 1, 3 and 6 months after treatment)	baseline, 1, 3 and 6 months	No