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Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-allergic Rhinitis

Intervention: Capsaicin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Peter Hellings, Prof. Dr., Principal Investigator, Affiliation: UZ Leuven

Overall contact:
Sofie Mees, Email: sofie.mees@med.kuleuven.be

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%.)

Clinical Details

Official title: Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change in visual analogue scale for major nasal symptoms

Secondary outcome:

change in visual analogue scale for individual nasal symptoms

change in therapeutic response in all treatment regimes

Change of nasal hyperreactivity in all treatment modalities.

Evaluation of appearance of adverse events in all treatment groups

Evaluation of recurrence of symptoms in all treatment modalities

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Sofie Mees, Email: sofie.mees@med.kuleuven.be

Additional Information

Starting date: January 2015
Last updated: November 10, 2014

Page last updated: August 20, 2015

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