Perennial Allergic RhinitisNCT04544774
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
An observational study of Perennial Allergic Rhinitis and Seasonal Allergic Rhinitis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy. The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, Local Allergic Rhinitis
- What is being tested?
- AIT and NAPT
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Jul 2020to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Adult
Study population: Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.
Who may be able to join
- Age >18 and ≤60 years
- Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs.
- OR suspected local allergic rhinitis
- Patients who start with AIT treatment
- The patient must be motivated and willing to come to all visits
- The patient must be able to understand and sign the informed consent
Who cannot join
- Uncontrolled asthma
- Conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases)
- Use of β-blockers, immunosuppressants or ACE inhibitors
- Hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in AIT
- Anaphylaxis after allergen challenge in the past
- Acute rhinosinusitis in the last 12 weeks
- Recent surgery on the nose and/or paranasal sinuses in the last 12 weeks
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
AZ Sint-Jan
Bruges, 8000
Kato Speleman, MD, 050452280, nok@azsintjan.be
- Recruiting
UZ Leuven
Leuven, Vlaam Brabant, 3000
Margot Vandekerckhove, +3216332342 ext. +3216332342, margot.vandekerckhove@uzleuven.be
Laura Van Gerven, +3216336390 ext. +3216336340, laura.vangerven@uzleuven.be
About this study
Official title: The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy.
The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years.
This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology
- Being tested
- AIT, NAPT
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AITDrug
AIT for airborn allergens (SCIT/SLIT)
NAPTDiagnostic test
NAPT test with airborn allergens ( HDM, Threes, Grasses)
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis patients | Patients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment. Receives: Drug: AIT; Diagnostic Test: NAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .
The effectiveness of AIT treatment will be analysed by comparing blood results, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
Measured: before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore.
The effectiveness of AIT treatment will be analysed by comparing the Lebelscores ,assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
Lebelscore has a range between 0 and 12.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22.
The effectiveness of AIT treatment will be analysed by comparing SNOT-22, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
SNOT-22 is sino-nasal outcome test with 22 items which ranges from 0 to 110.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS.
The effectiveness of AIT treatment will be analysed by comparing VAS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
The visual analogue scale (VAS) ranges from 0 to 10cm for every item.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.
The effectiveness of AIT treatment will be analysed by comparing TNSS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
Total nasal symptom score (TNSS) ranges from 0 to 12.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.
The effectiveness of AIT treatment will be analysed by comparing ACT, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
ACT is the Asthma control test with scores between 0 and 25. The higher the score the better.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.
The effectiveness of AIT treatment will be analysed by comparing RQLQ, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
RQLQ is the rhinoconjunctivits quality of life questionnaire with scores between 0 and 168.
The higher the score of these questionnaires the more discomfort.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.
The effectiveness of AIT treatment will be analysed by comparing TRE, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
TRE is the therapeutic response evaluation and will be scored between 'much better' and 'much worse'.
Measured: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment assessed by the change in the PNIF value.
The effectiveness of AIT treatment will be analysed by comparing PNIF values assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). PNIF is the peak nasal inspiratory flow with a value between 0 and 370 l/min). The higher the value the less congested the nose is.
Measured: Before start AIT, every 6 months en after 3 years
Secondary outcomes (2)
Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.
Measured: 3 years
Calculating the cost savings by timely stopping AIT treatment in non-responders, which we can define as patients who do not experience subjective or objective improvement after 1 year of treatment.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start16 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544774
- Sponsor's protocol ID
- s63711
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
- ClinicalTrials.gov ID
- NCT04544774
- Acronym / sponsor ID
- s63711
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Sep 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.
This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy.
The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years.
This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis patients | – | Drug: AIT, Diagnostic Test: NAPTPatients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.
Key inclusion criteria (6 listed)
- Age >18 and ≤60 years
- Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs.
- OR suspected local allergic rhinitis
- Patients who start with AIT treatment
- The patient must be motivated and willing to come to all visits
Key exclusion criteria (8 listed)
- Uncontrolled asthma
- Conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases)
- Use of β-blockers, immunosuppressants or ACE inhibitors
- Hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in AIT
- Anaphylaxis after allergen challenge in the past
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 |
|---|---|---|
| AITAIT for airborn allergens (SCIT/SLIT) | Drug | Allergic rhinitis patients |
| NAPTNAPT test with airborn allergens ( HDM, Threes, Grasses) | Diagnostic test | Allergic rhinitis patients |
Primary outcome
The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .
Time frame: before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing blood results, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing the Lebelscores ,assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Lebelscore has a range between 0 and 12.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing SNOT-22, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). SNOT-22 is sino-nasal outcome test with 22 items which ranges from 0 to 110.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing VAS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). The visual analogue scale (VAS) ranges from 0 to 10cm for every item.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing TNSS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Total nasal symptom score (TNSS) ranges from 0 to 12.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing ACT, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). ACT is the Asthma control test with scores between 0 and 25. The higher the score the better.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing RQLQ, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). RQLQ is the rhinoconjunctivits quality of life questionnaire with scores between 0 and 168. The higher the score of these questionnaires the more discomfort.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing TRE, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). TRE is the therapeutic response evaluation and will be scored between 'much better' and 'much worse'.
The effectiveness of AIT treatment assessed by the change in the PNIF value.
Time frame: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing PNIF values assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). PNIF is the peak nasal inspiratory flow with a value between 0 and 370 l/min). The higher the value the less congested the nose is.
2 secondary outcomes
Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.
Time frame: 3 years
Calculating the cost savings by timely stopping AIT treatment in non-responders, which we can define as patients who do not experience subjective or objective improvement after 1 year of treatment.
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perennial Allergic Rhinitis and Seasonal Allergic Rhinitis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margot Vandekerckhove (+3216332342, margot.vandekerckhove@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE . (time frame: before start AIT, every 6 months en after 3 years). The study lists 9 primary outcomes in all. 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 1 May 2026.