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
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