Nasal Hyper ReactivityNCT02334605
Comparison of Cold Dry Air Exposure, Discs and Capsaicin
A study testing cold dry air, hyperosmolar discs and capsaicin nasal spray in people with Nasal Hyper Reactivity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Hyper Reactivity
- What is being tested?
- cold dry air, hyperosmolar discs and capsaicin nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. *
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- Age > 18 and < 65 years.
- Written informed consent.
- Willingness to adhere to the planned visits.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
emily dekimpe, MsC contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven ENT
Leuven, Vlaams Brabant, 3000
emily dekimpe, msc, 003216340757, emily.dekimpe@uzleuven.be
Peter Hellings, Prof Dr
About this study
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.
Read more
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
- Being tested
- cold dry air, hyperosmolar discs, capsaicin nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold dry airOther
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 discsDevice
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 sprayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: 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. Receives: Device: capsaicin nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peak nasal inflamatorry flow
Measured: baseline, 5 minutes
Secondary outcomes (1)
change of nasal symptom visual analogue scale
Measured: baseline, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Hyper ReactivityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- peter hellings, Prof Dr, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334605
- Sponsor's protocol ID
- CDAvsDiscsvsCap
- Status last verified
- Dec 2015
- First submitted
- 6 Jan 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cold Dry Air Exposure, Hyperosmolar Sponge and Capsaicin Nasal Spray for Objective Evaluation of Nasal Hyperreactivity
- ClinicalTrials.gov ID
- NCT02334605
- Acronym / sponsor ID
- CDAvsDiscsvsCap
- Conditions
- Nasal Hyper Reactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cold dry air | Other | Other: cold dry airPatients 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 | Other | Device: hyperosmolar discsA 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 | Other | Device: capsaicin nasal sprayone 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- Individuals with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold dry airPatients 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 discsA 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 |
| capsaicin nasal spray1 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 | capsaisin nasal spray |
Primary outcome
change in peak nasal inflamatorry flow
Time frame: baseline, 5 minutes
1 secondary outcome
change of nasal symptom visual analogue scale
Time frame: baseline, 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emily dekimpe, MsC contact
peter hellings, Prof Dr principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold dry air, hyperosmolar discs and capsaicin nasal spray in people with Nasal Hyper Reactivity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emily dekimpe, MsC (emily.dekimpe@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in peak nasal inflamatorry flow (time frame: baseline, 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.