Phase 4
N=80
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Non-allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT02288156 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Visual Analogue Scale for Major Nasal Symptoms — 3.66; 4.29; 4.49; 5.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Capsaicin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analogue Scale for Major Nasal Symptoms |
3.66; 4.29; 4.49; 5.6; 8.36; 8.03 | — |
| SECONDARY Change in Visual Analogue Scale for Individual Nasal Symptoms |
7.594; 5.994; 4.212; 5.806; 2.738; 2.313 | — |
| SECONDARY Therapeutic Response in All Treatment Regimes |
70; 82; 35; 23 | — |
| SECONDARY Change of Nasal Hyperreactivity in All Treatment Modalities. |
7; 9; 8; 9; 5; 5 | — |
| SECONDARY Number of Adverse Events in All Treatment Groups |
27; 24; 32; 29 | — |
| SECONDARY Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities |
10; 6; 10; 12 | — |
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 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%.)
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02288156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.