Original Query: ALL
Previous Study | Return to List | Next Study

Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01862523
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Rhinitis Biological: Capsaicin Biological: diluent Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : February 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: diluent
Biological: diluent
Experimental: 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

Primary Outcome Measures :
  1. negative mucosa potentials [ Time Frame: baseline, 1, 3 and 6 months ]
    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 :
  1. visual analogue scale [ Time Frame: baseline, 1, 3 and 6 months ]
    change of visual analogue scale of the administered stimuli (baseline vs 1, 3 and 6 months after treatment)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01862523

UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 8000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Laura Van Gerven, Doctor UZ Leuven
Principal Investigator: Peter Hellings, Doctor UZ Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01862523     History of Changes
Other Study ID Numbers: mucosal potentials in the nose
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs