HyperactivityNCT04286542
Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
A study testing Cold, dry air in people with Hyperactivity and Allergic Rhinitis Due to House Dust Mite, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperactivity, Allergic Rhinitis Due to House Dust Mite, Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Cold, dry air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2020to Dec 2022
- 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
- 18-65 years
- positive skin prick test for house dust mite (for allergic rhinitis group), presence of nasal polyps (for chronic rhinosinusitis with nasal polyps group)
- VAS-score >5 for rhino(sinus)itis symptoms
Who cannot join
- positive skin prick test (for chronic rhinosinusitis with nasal polyps group and healthy control group), presence of nasal polyps (for allergic rhinitis group and healthy control group)
- Acute rhinitis in the past 2 weeks
- (History of) immunotherapy for house dust mite
- Relevant anatomic abnormalities
- Participation in another clinical trial at the moment of this study.
- Use of anticoagulants (apart from acetylsalicylic acid)
Show all 10Show fewer
- Use of tricyclic antidepressants
- History of intranasal drug usage in the past 12 months
- Pregnancy or breastfeeding
- Malignancy or severe comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS).
Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances… a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not.
In this study, the investigators want to identify the mediators associated with NHR in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.To do so, participants will be provoked with cold, dry air in order to objectively diagnose NHR. Before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).
Read the detailed description
Patients with perennial allergic rhinitis, chronic rhinosinusitis with nasal polyps and healthy control subjects will be recruited. At baseline, nasal secretions and mucosal biopsies will be collected. After 3 weeks, participants will be provoked with cold, dry air, and samples will be harvested again. A decrease in the peak nasal inspiratory flow of >20% will be used as a cutoff to define nasal hyperreactivity.
Nasal secretions will be analysed for various mediators using a multiplex assay. The biopsies will be used for RT-q-PCR and immunohistochemistry of various transient receptor potential (TRP) channels.
- Conditions
- Hyperactivity, Allergic Rhinitis Due to House Dust Mite, Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Cold, dry air
- Medical subject headings
- Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold, dry airDiagnostic test
Participants will be exposed to cold (<-10°C, <10% relative humidity), dry air for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Provocation with cold air | Experimental | Participants will be exposed to cold dry air for 15 minutes Receives: Diagnostic Test: Cold, dry air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective nasal hyperreactivity
The peak nasal inspiratory flow will be measured before and after provocation with cold, dry air. A decrease of >20% will be used as a cutoff to objectively diagnose nasal hyperreactivity.
Measured: 3 weeks
Secondary outcomes (12)
Levels of histamine in nasal secretions
In nasal secretions, the investigators will measure the levels of histamine by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of tryptase in nasal secretions
In nasal secretions, the investigators will measure the levels of tryptase by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of substance P in nasal secretions
In nasal secretions, the investigators will measure the levels of substance P by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of neurokinin A in nasal secretions
In nasal secretions, the investigators will measure the levels of neurokinin A by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of neurokinin B in nasal secretions
In nasal secretions, the investigators will measure the levels of neurokinin B by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of calcitonin gene-related peptide in nasal secretions
In nasal secretions, the investigators will measure the levels of calcitonin gene-related peptide by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of interleukin (IL) 4 in nasal secretions
In nasal secretions, the investigators will measure the levels of IL-4 by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of IL-5 in nasal secretions
In nasal secretions, the investigators will measure the levels of IL-5 by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Levels of IL-13 in nasal secretions
In nasal secretions, the investigators will measure the levels of IL-13 by using a multiplex assay. They will do so at baseline and after cold dry air provocation test.
Measured: 3 weeks
Presence of TRP Vanilloid 1 in nasal mucosa.
The investigators will determine the presence of TRP vanilloid 1 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
Measured: 3 weeks
Presence of TRP Ankyrin 1 in nasal mucosa.
The investigators will determine the presence of TRP Ankyrin 1 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
Measured: 3 weeks
Presence of TRP Melastatin 8 in nasal mucosa.
The investigators will determine the presence of TRP Melastatin 8 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start20 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperactivityStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Visit 1: screening, baseline sample collection. Visit 2: sample collection, provocation with cold dry air, sample collection
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286542
- Sponsor's protocol ID
- S63139
- Status last verified
- May 2022
- First submitted
- 21 Feb 2020
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04286542
- Acronym / sponsor ID
- S63139
- Conditions
- Hyperactivity, Allergic Rhinitis Due to House Dust Mite, Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- 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.
Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS).
Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances… a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not.
In this study, the investigators want to identify the mediators associated with NHR in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.To do so, participants will be provoked with cold, dry air in order to objectively diagnose NHR. Before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).
Detailed description
Patients with perennial allergic rhinitis, chronic rhinosinusitis with nasal polyps and healthy control subjects will be recruited. At baseline, nasal secretions and mucosal biopsies will be collected. After 3 weeks, participants will be provoked with cold, dry air, and samples will be harvested again. A decrease in the peak nasal inspiratory flow of >20% will be used as a cutoff to define nasal hyperreactivity.
Nasal secretions will be analysed for various mediators using a multiplex assay. The biopsies will be used for RT-q-PCR and immunohistochemistry of various transient receptor potential (TRP) channels.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Visit 1: screening, baseline sample collection. Visit 2: sample collection, provocation with cold dry air, sample collection
| Arm | Type | Receives |
|---|---|---|
| Provocation with cold air | Experimental | Diagnostic Test: Cold, dry airParticipants will be exposed to cold dry air for 15 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years
- positive skin prick test for house dust mite (for allergic rhinitis group), presence of nasal polyps (for chronic rhinosinusitis with nasal polyps group)
- VAS-score >5 for rhino(sinus)itis symptoms
Key exclusion criteria (10 listed)
- positive skin prick test (for chronic rhinosinusitis with nasal polyps group and healthy control group), presence of nasal polyps (for allergic rhinitis group and healthy control group)
- Acute rhinitis in the past 2 weeks
- (History of) immunotherapy for house dust mite
- Relevant anatomic abnormalities
- Participation in another clinical trial at the moment of this study.
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 airParticipants will be exposed to cold (<-10°C, <10% relative humidity), dry air for 15 minutes. | Diagnostic test | Provocation with cold air |
Primary outcome
Objective nasal hyperreactivity
Time frame: 3 weeks
The peak nasal inspiratory flow will be measured before and after provocation with cold, dry air. A decrease of >20% will be used as a cutoff to objectively diagnose nasal hyperreactivity.
12 secondary outcomes
Levels of histamine in nasal secretions
Time frame: 3 weeks
Levels of tryptase in nasal secretions
Time frame: 3 weeks
Levels of substance P in nasal secretions
Time frame: 3 weeks
Levels of neurokinin A in nasal secretions
Time frame: 3 weeks
Levels of neurokinin B in nasal secretions
Time frame: 3 weeks
Levels of calcitonin gene-related peptide in nasal secretions
Time frame: 3 weeks
Levels of interleukin (IL) 4 in nasal secretions
Time frame: 3 weeks
Levels of IL-5 in nasal secretions
Time frame: 3 weeks
Levels of IL-13 in nasal secretions
Time frame: 3 weeks
Presence of TRP Vanilloid 1 in nasal mucosa.
Time frame: 3 weeks
Presence of TRP Ankyrin 1 in nasal mucosa.
Time frame: 3 weeks
Presence of TRP Melastatin 8 in nasal mucosa.
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Hyperactivity and Allergic Rhinitis Due to House Dust Mite, 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 3 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 25 May 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective nasal hyperreactivity (time frame: 3 weeks). 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 25 May 2022.