Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01862523
First received: September 5, 2012
Last updated: March 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rhinitis
Biological: Capsaicin
Biological: diluent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Unraveling the Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls by Measuring Mucosal Potentials in the Nose.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • negative mucosa potentials [ Time Frame: baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]
    change in negative mucosa potentials (baseline vs 1, 3 and 6 months after treatment)by measurement of AUC, delay-time and amplitude


Secondary Outcome Measures:
  • visual analogue scale [ Time Frame: baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]
    change of visual analogue scale of the administered stimuli (baseline vs 1, 3 and 6 months after treatment)


Estimated Enrollment: 41
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: diluent
diluent
Biological: diluent
diluent
Other Name: diluent
Experimental: capsaicin
capsaicin
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)
No Intervention: control healthy volunteers
control healthy volunteers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862523

Contacts
Contact: Laura Van Gerven, Doctor laura.vangerven@uzleuven.be

Locations
Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 8000
Contact: Laura Van Gerven, Doctor         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Laura Van Gerven, Doctor UZ Leuven
Principal Investigator: Peter Hellings, Doctor UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01862523     History of Changes
Other Study ID Numbers: mucosal potentials in the nose
Study First Received: September 5, 2012
Last Updated: March 7, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014