Non-allergic RhinitisPhase 4NCT02288156
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
A Phase 4 study testing Capsaicin in people with Non-allergic Rhinitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-allergic Rhinitis
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
- idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
- Age > 18 and < 65 years.
- Written informed consent.
- Willingness to adhere to visit schedules.
- Adequate contraceptive precautions in female patients with childbearing potential.
Who cannot join
- Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. *
- Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
- Patients with local allergic rhinitis (LAR) or entopy.
- 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 like ß-blockers.
- History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
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- Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
- Pregnancy or lactation. **
- 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 receiving other investigational agent(s) for any other medical condition.
- Contra-indications for the use of local anesthesia (cocaine 5%).
- Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
- Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in VAS for major nasal symptom on week 4.
(Estimated placebo effect is 25%.)
- Conditions
- Non-allergic Rhinitis
- Being tested
- Capsaicin, placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
via nasal spray
placeboDrug
via nasal spray
| Study group | Role | What they receive |
|---|---|---|
| 0.1mM | Active comparator | Not described Receives: Drug: Capsaicin |
| 0.01mM | Experimental | Not described Receives: Drug: Capsaicin |
| 0.001mM | Experimental | Not described Receives: Drug: Capsaicin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale for Major Nasal Symptoms
patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
Measured: Baseline and week 4
Secondary outcomes (5)
Change in Visual Analogue Scale for Individual Nasal Symptoms
patients score all kinds of nasal symptoms from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
Measured: Baseline, week 4
Therapeutic Response in All Treatment Regimes
Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms).
Measured: week 4
Change of Nasal Hyperreactivity in All Treatment Modalities.
change in the number of participants with nasal hyperreactivity in all treatment modalities
Measured: baseline, week 4
Number of Adverse Events in All Treatment Groups
All reported AEs were entered into the AE section so please see AE table for specifics.
Measured: week 4
Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities
Measured: week 4, 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-allergic RhinitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Hellings, Prof. Dr., Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288156
- Sponsor's protocol ID
- TBM
- Status last verified
- May 2021
- First submitted
- 6 Nov 2014
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Van Gerven L, Steelant B, Cools L, Callebaut I, Backaert W, de Hoon J, Ampe E, Talavera K, Hellings PW. Low-dose capsaicin (0.01 mM) nasal spray is equally effective as the current standard treatment for idiopathic rhinitis: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2021 Jan;147(1):397-400.e4. doi: 10.1016/j.jaci.2020.04.054. Epub 2020 May 19. No abstract available.
PubMed 32439432