Status:
COMPLETED
Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 fun...
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 eff...
Eligibility Criteria
Inclusion
- 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.
- Age \> 18 and \< 60 years
- Written informed consent
- Willingness to adhere to visit schedules
- Adequate contraceptive precautions in female patients with childbearing potential
- Unresponsiveness to nasal steroid spray (4 weeks of use)
Exclusion
- Age \< 18 and \> 60 years
- Patients with AR, demonstrated by either positive skin prick test or RAST
- Asthma
- Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
- Systemic steroid treatment less than 4 weeks before the inclusion in the study.
- Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
- Inability of the patient to stop taking medication affecting nasal function.
- Evidence of infectious rhinitis/rhinosinusitis.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01862523
Start Date
February 1 2012
End Date
December 1 2014
Last Update
December 5 2014
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 8000