Comparison of Cold Dry Air Exposure, Discs and Capsaicin

Condition(s) targeted: Nasal Hyper Reactivity

Intervention: cold dry air (Other); hyperosmolar discs (Device); capsaicin nasal spray (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
peter hellings, Prof Dr, Principal Investigator, Affiliation: KU Leuven

Overall contact:
emily dekimpe, MsC, Email: emily.dekimpe@uzleuven.be

Nasal hyper reactivity is defined as an increased sensitivity of the nasal mucosa to stimuli such as temperature changes, changes in humidity, emotional stress, physical activity, smoke and/or other scents and gives often rise to nasal symptoms such as rhinorrhea, nasal obstruction and/or sneezing. nasal hyper reactivity is a clinical feature of rhinitis and rhinosinusitis, affecting more than 20% of the total Western population. Cold, dry air exposure has been shown to be a reliable method for diagnosis of nasal hyperreactivity. The new, shorter protocol for cold dry air provocation that recently has been validated as a useful diagnostic tool to evaluate nasal hyperreactivity with high specificity and sensitivity, is already a major step forward but still rather time-consuming and not always very practical in use. A hyperosmolar saline solution loaded on a small nasal sponge as described earlier has also been reported as being an effective means of evaluation of nasal hyperreactivity. In addition, capsaicin nasal spray has also been reported as being an elegant tool for the evaluation of the response of TRP channels on the nasal mucosa. So far, we lack data on the comparison between the 3 different diagnostic tools for the evaluation of nasal hyperreactivity in rhinitis.

Official title: Comparison of Cold Dry Air Exposure, Hyperosmolar Sponge and Capsaicin Nasal Spray for Objective Evaluation of Nasal Hyperreactivity

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: change in peak nasal inflamatorry flow

Secondary outcome: change of nasal symptom visual analogue scale

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

Criteria:

Inclusion Criteria: DM AR patients with at least two nasal complaints rhinorrhea, nasal obstruction, itch or sneezing.

- HDM AR patients with a total nasal symptoms score (TNS) of 5 or more on a visual

analogue scale (VAS).

- HDM AR patients with positive skin prick test (Hal reagents) for house dust mite

and/or IgE in blood. *

- IR patients with at least two nasal complaints rhinorrhea, nasal obstruction, itch or

sneezing.

- IR patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue

scale (VAS).

- HC with no rhinological complaints during the previous three months with negative

skin prick test (Hal reagents) for the 18 most frequent aeroallergens in Belgium. *

- Age > 18 and < 65 years.

- Written informed consent.

- Willingness to adhere to the planned visits.

Exclusion Criteria:

- Individuals with structural abnormalities: nasal polyps, severe septal deviation

(septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.

- Individuals 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 person 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.

- 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.

- Smoking or occupational exposure to irritants (like hypochlorite, persulfates,

isocyanates).

- Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.

emily dekimpe, MsC, Email: emily.dekimpe@uzleuven.be

UZ Leuven ENT, Leuven, Vlaams Brabant 3000, Belgium; Recruiting
emily dekimpe, msc, Phone: 003216340757, Email: emily.dekimpe@uzleuven.be
Peter Hellings, Prof Dr, Principal Investigator

Starting date: January 2015
Last updated: January 7, 2015