Comparison of Cold Dry Air Exposure, Discs and Capsaicin
NCT ID: NCT02334605
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2015-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
cold dry air
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
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%.
hyperosmolar discs
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
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.
capsaisin nasal spray
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.
capsaicin nasal spray
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cold dry air
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%.
hyperosmolar discs
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.
capsaicin nasal spray
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
peter hellings, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Leuven ENT
Leuven, Vlaams Brabant, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDAvsDiscsvsCap
Identifier Type: -
Identifier Source: org_study_id