Idiopathic Rhinitis PatientsPhase 4NCT01223820
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
A Phase 4 study testing Capsaicin in people with Idiopathic Rhinitis Patients and Healthy Controls, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The term idiopathic rhinitis (IR) is used in this study to describe a patient group with following characteristics: patients with complaints of nasal obstruction, sneezing and/or rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or paranasal infection, anatomical disorders, pregnancy… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Rhinitis Patients, Healthy Controls
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with persistent (> 12w) 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 < 50 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)
Who cannot join
- Age < 18 and > 50 years
- Patients with AR, demonstrated by either positive skin prick test or RAST
- Presence of IgE in nasal lavage fluid
- 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.
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- Inability of the patient to stop taking medication affecting nasal function.
- Evidence of infectious rhinitis/rhinosinusitis.
- Pregnancy or breastfeeding.
- Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
- Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
- Contra-indications for local anaesthesia (Cocaïne 5%).
- Smoking.
- Systemic disease with lesions in ENT domain.
- Malignancies or severe comorbidity.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Leuven, NKO-GH Kapucijnenvoer 33
Leuven, Vlaams-Brabant, 3000
About this study
The term idiopathic rhinitis (IR) is used in this study to describe a patient group with following characteristics: patients with complaints of nasal obstruction, sneezing and/or rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders. These patients are non-smokers and do not use medication affecting nasal function. They have no beneficial effect of intranasal steroid spray (INS) treatment.
The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR is largely unknown. Several hypotheses have been put forward. In general it is assumed that neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli and can be responsible for the symptoms of IR.
Read more
For this group of IR-patients, there is until now only one treatment option: intranasal capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its' therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.
The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces in that way nasal symptoms.
- Conditions
- Idiopathic Rhinitis Patients, Healthy Controls
- Being tested
- Capsaicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
5x nasal application in one day, 1 hour between each application
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | Not described Receives: Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-immunological effect.
The primary aim of the study is to identify the neuro-immunological effects induced by capsaicin nasal spray in IR patients and healthy individuals.
Measured: 6 months
Secondary outcomes (1)
TR-PNIF-CDA
The secondary aim of this study is to correlate the neuro-immunological findings with the therapeutic response to capsaicin, the nasal congestion using the peak nasal inspiratory (PNIF), and nasal response to Cold Dry Air (CDA)-provocation.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Rhinitis PatientsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Laura H Van Gerven, MD, Principal investigator, UZ LeuvenPeter W Hellings, MD, PhD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223820
- Sponsor's protocol ID
- Nasal Capsaicin treatment
- Status last verified
- Sep 2011
- First submitted
- 18 Oct 2010
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes