Comparison of Cold Dry Air Exposure, Discs and Capsaicin

NCT02334605 | Unknown

• 1 other identifier: CDAvsDiscsvsCap
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Hyper Reactivity

Outcome Measures

Primary Outcomes (1)

• change in peak nasal inflamatorry flow

  baseline, 5 minutes

Secondary Outcomes (1)

• change of nasal symptom visual analogue scale

  baseline, 5 minutes

Study Arms (3)

cold dry air

OTHER

Patients will be asked to acclimatize to room temperature for 20 minutes prior to exposure to cold dry air. Through a nasal cannula, compressed dry air for medical use will be delivered for 15 minutes (25L/minute). Patients will be instructed to breathe through the nose only. The temperature of the air reaching the nose will be approximately -10°C and the relative humidity less than 10-15%.

Other: cold dry air

hyperosmolar discs

OTHER

A small paper disc (5-6mm of diameter) previously loaded with 50µl NaCl 5,13M will be applied on the right nasal septum for 1 minute and then be discarded.

Device: hyperosmolar discs

capsaisin nasal spray

OTHER

one puff of a nasal spray with a solution of capsaicin 0,0001mM will be sprayed in each nostril of the subject and subjects will be asked to score visual analogue scale for irritation of the nasal mucosa immediately after the adminitration.

Device: capsaicin nasal spray

Interventions

cold dry air OTHER

Patients will be asked to acclimatize to room temperature for 20 minutes prior to exposure to cold dry air. Through a nasal cannula, compressed dry air for medical use will be delivered for 15 minutes (25L/minute). Patients will be instructed to breathe through the nose only. The temperature of the air reaching the nose will be approximately -10°C and the relative humidity less than 10-15%.

cold dry air

hyperosmolar discs DEVICE

A small paper disc (5-6mm of diameter) previously loaded with 50µl NaCl 5,13M will be applied on the right nasal septum for 1 minute and then be discarded.

hyperosmolar discs

capsaicin nasal spray DEVICE

1 puff of a nasal spray with a solution of capsaicin 0,0001mM will be sprayed in each nostril of the subject and subjects will be asked to score visual analogue scale for irritation of the nasal mucosa immediately after the adminitration.

capsaisin nasal spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven ENT

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Study Officials

• peter hellings, Prof Dr

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

emily dekimpe, MsC

CONTACT

emily.dekimpe@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

BE (1)