idiopathic rhinitis
Conditions
Interventions
Product Name: capsaicin 0.1
Product Code: capsaicin
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: NA
Other descriptive name: CAPSAICIN (HOUSE STANDARD)
Concentration unit: mmol/l mil
Sponsors
uzleuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • IR patients with at least 1 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day, • IR patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS). • Age > 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or IgE 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 anaesthesia (cocaïne 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 |
|---|---|
| Main Objective: • To evaluate if the two novel treatment modalities show non-inferiority compared to the current treatment modality of capsaicin nasal treatment in 120 patients with IR. The gathered data of this single center trial can be used to guide the decision on the set-up and the design of a larger multi-center trial being powered to prove non-inferiority.;Secondary Objective: • To confirm the validity of CDA challenge and challenge with hyperosmolar discs as a clinical tool for the demonstration of the reduction of NHR by capsaicin nasal spray. • To evaluate the occurrence of adverse events and recurrence of symptoms and NHR in the different treatment groups at week 4 and 12. ;Primary end point(s): • Comparison of VAS for major nasal symptom at week 4 in all treatments modalities. The region of equivalence of the compared treatment modalities is defined as a difference in VAS of less than 1. ;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Comparison of VAS for total and individual nasal symptoms at week 4 in all treatments modalities. • Comparison of TRE in all treatment regimes at week 4. • Comparison of the reduction of NHR (measured by CDA challenge and hyperosmolar discs) in all treatment modalities. • Evaluation of appearance of adverse events in all treatment groups at week 4 and 12. • Evaluation of recurrence of symptoms in all treatment modalities at week 4, 12 and 26. ;Timepoint(s) of evaluation of this end point: after 4, 12 and 26 weeks of treatment | — |
Countries
Belgium
Contacts
Public Contactuz leuven
uzleuven
Outcome results
None listed