Non-allergic Rhinitis
Conditions
Brief 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%.)
Interventions
DRUGCapsaicin
via nasal spray
DRUGplacebo
via nasal spray
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale for Major Nasal Symptoms | Baseline and week 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale for Individual Nasal Symptoms | Baseline, week 4 | 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 |
| Therapeutic Response in All Treatment Regimes | week 4 | Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms). |
| Change of Nasal Hyperreactivity in All Treatment Modalities. | baseline, week 4 | change in the number of participants with nasal hyperreactivity in all treatment modalities |
| Number of Adverse Events in All Treatment Groups | week 4 | All reported AEs were entered into the AE section so please see AE table for specifics. |
| Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | week 4, 12 and 26 | — |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0,1mM Capsaicin: via nasal spray | 16 |
| 0,01mM Capsaicin: via nasal spray | 16 |
| 0.001mM Capsaicin: via nasal spray | 18 |
| Placebo placebo: via nasal spray | 18 |
| Total | 68 |
Baseline characteristics
| Characteristic | 0,1mM | 0,01mM | 0.001mM | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50 Years STANDARD_DEVIATION 14 | 45 Years STANDARD_DEVIATION 10 | 48 Years STANDARD_DEVIATION 14 | 45 Years STANDARD_DEVIATION 15 | 47 Years STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 9 Participants | 10 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 10 / 16 | 8 / 16 | 14 / 18 | 12 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 18 | 0 / 18 |
Outcome results
Primary
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
Time frame: Baseline and week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0,1mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Week 4 | 3.66 score on a scale | Standard Deviation 2.78 |
| 0,1mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Baseline | 8.36 score on a scale | Standard Deviation 1.68 |
| 0,01mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Baseline | 8.03 score on a scale | Standard Deviation 1.36 |
| 0,01mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Week 4 | 4.29 score on a scale | Standard Deviation 2.92 |
| 0.001mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Week 4 | 4.49 score on a scale | Standard Deviation 2.93 |
| 0.001mM | Change in Visual Analogue Scale for Major Nasal Symptoms | Baseline | 7.74 score on a scale | Standard Deviation 1.48 |
| Placebo | Change in Visual Analogue Scale for Major Nasal Symptoms | Week 4 | 5.6 score on a scale | Standard Deviation 1.67 |
| Placebo | Change in Visual Analogue Scale for Major Nasal Symptoms | Baseline | 8.24 score on a scale | Standard Deviation 1.51 |
Secondary
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
Time frame: Baseline, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0,1mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Baseline | 7.594 score on a scale | Standard Deviation 2.569 |
| 0,1mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Week 4 | 2.738 score on a scale | Standard Deviation 2.796 |
| 0,01mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Week 4 | 2.313 score on a scale | Standard Deviation 2.572 |
| 0,01mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Baseline | 5.994 score on a scale | Standard Deviation 3.305 |
| 0.001mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Baseline | 4.212 score on a scale | Standard Deviation 3.318 |
| 0.001mM | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Week 4 | 2.383 score on a scale | Standard Deviation 2.868 |
| Placebo | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Baseline | 5.806 score on a scale | Standard Deviation 3.751 |
| Placebo | Change in Visual Analogue Scale for Individual Nasal Symptoms | Rhinorrhea Week 4 | 3.018 score on a scale | Standard Deviation 2.325 |
Secondary
Change of Nasal Hyperreactivity in All Treatment Modalities.
change in the number of participants with nasal hyperreactivity in all treatment modalities
Time frame: baseline, week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0,1mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | Baseline | 7 participants |
| 0,1mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | week 4 | 5 participants |
| 0,01mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | week 4 | 5 participants |
| 0,01mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | Baseline | 9 participants |
| 0.001mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | Baseline | 8 participants |
| 0.001mM | Change of Nasal Hyperreactivity in All Treatment Modalities. | week 4 | 4 participants |
| Placebo | Change of Nasal Hyperreactivity in All Treatment Modalities. | Baseline | 9 participants |
| Placebo | Change of Nasal Hyperreactivity in All Treatment Modalities. | week 4 | 8 participants |
Secondary
Number of Adverse Events in All Treatment Groups
All reported AEs were entered into the AE section so please see AE table for specifics.
Time frame: week 4
Population: All reported AEs were entered into the AE section so please see AE section for specifics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0,1mM | Number of Adverse Events in All Treatment Groups | 27 Total number of events |
| 0,01mM | Number of Adverse Events in All Treatment Groups | 24 Total number of events |
| 0.001mM | Number of Adverse Events in All Treatment Groups | 32 Total number of events |
| Placebo | Number of Adverse Events in All Treatment Groups | 29 Total number of events |
Secondary
Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities
Time frame: week 4, 12 and 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0,1mM | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | 10 Participants |
| 0,01mM | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | 6 Participants |
| 0.001mM | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | 10 Participants |
| Placebo | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | 12 Participants |
Secondary
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).
Time frame: week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0,1mM | Therapeutic Response in All Treatment Regimes | 70 percentage of patients with improvement |
| 0,01mM | Therapeutic Response in All Treatment Regimes | 82 percentage of patients with improvement |
| 0.001mM | Therapeutic Response in All Treatment Regimes | 35 percentage of patients with improvement |
| Placebo | Therapeutic Response in All Treatment Regimes | 23 percentage of patients with improvement |