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Comparison of Cold Dry Air Exposure, Discs and Capsaicin

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ClinicalTrials.gov Identifier: NCT02334605
Recruitment Status : Unknown
Verified December 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : January 8, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Nasal Hyper Reactivity Other: cold dry air Device: hyperosmolar discs Device: capsaicin nasal spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Cold Dry Air Exposure, Hyperosmolar Sponge and Capsaicin Nasal Spray for Objective Evaluation of Nasal Hyperreactivity
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
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%.

Other: 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.
Device: 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.
Device: 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.




Primary Outcome Measures :
  1. change in peak nasal inflamatorry flow [ Time Frame: baseline, 5 minutes ]

Secondary Outcome Measures :
  1. change of nasal symptom visual analogue scale [ Time Frame: baseline, 5 minutes ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334605


Contacts
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Contact: emily dekimpe, MsC emily.dekimpe@uzleuven.be

Locations
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Belgium
UZ Leuven ENT Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: emily dekimpe, msc    003216340757    emily.dekimpe@uzleuven.be   
Principal Investigator: Peter Hellings, Prof Dr         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: peter hellings, Prof Dr KU Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02334605    
Other Study ID Numbers: CDAvsDiscsvsCap
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs