Non-allergic Rhinitis Clinical Trial
Official title:
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
NCT number | NCT02288156 |
Other study ID # | TBM |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | December 2018 |
Verified date | May 2021 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.)
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | ORL | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | Baseline and week 4 | |
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 | Baseline, week 4 | |
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). | week 4 | |
Secondary | Change of Nasal Hyperreactivity in All Treatment Modalities. | change in the number of participants with nasal hyperreactivity in all treatment modalities | baseline, week 4 | |
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. | week 4 | |
Secondary | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | week 4, 12 and 26 |
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