Nasal Hyper Reactivity Clinical Trial
Official title:
Comparison of Cold Dry Air Exposure, Hyperosmolar Sponge and Capsaicin Nasal Spray for Objective Evaluation of Nasal Hyperreactivity
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.
| Status | Recruiting |
| Enrollment | 36 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Leuven ENT | Leuven | Vlaams Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in peak nasal inflamatorry flow | baseline, 5 minutes | No | |
| Secondary | change of nasal symptom visual analogue scale | baseline, 5 minutes | No |