The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy

NCT04544774 | Recruiting

• 1 other identifier: s63711
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Perennial Allergic Rhinitis; Local Allergic Rhinitis; Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (9)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  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'.

  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.

  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.

  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.

  3 year

Study Arms (1)

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.

Drug: AIT; Diagnostic Test: NAPT

Interventions

AIT DRUG

AIT for airborn allergens (SCIT/SLIT)

Allergic rhinitis patients

NAPT DIAGNOSTIC_TEST

NAPT test with airborn allergens ( HDM, Threes, Grasses)

Allergic rhinitis patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: collaborator
• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

UZ Leuven

Leuven, Vlaam Brabant, 3000, Belgium

RECRUITING

AZ Sint-Jan

Bruges, 8000, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Margot Vandekerckhove

CONTACT

+3216332342; margot.vandekerckhove@uzleuven.be

Laura Van Gerven, PhD

CONTACT

+3216336340; laura.vangerven@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Laura Van Gerven

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 10, 2020
• Study Start: July 16, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)