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

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

Study Overview

• Status: Recruiting
• Conditions: Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis; Local Allergic Rhinitis
• Intervention / Treatment: Drug: AIT; Diagnostic test: NAPT

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Margot Vandekerckhove; Phone Number: +3216332342; Email: margot.vandekerckhove@uzleuven.be
• Study Contact Backup: Name: Laura Van Gerven, PhD; Phone Number: +3216336340; Email: laura.vangerven@uzleuven.be

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Not yet recruiting
    • AZ Sint-Jan
    • Contact: Kato Speleman, MD; Phone Number: 050452280; Email: nok@azsintjan.be
  • Vlaam Brabant
    • Leuven, Vlaam Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Margot Vandekerckhove; Phone Number: +3216332342 +3216332342; Email: margot.vandekerckhove@uzleuven.be
      • Contact: Laura Van Gerven; Phone Number: +3216336340 +3216336390; Email: laura.vangerven@uzleuven.be
      • Principal Investigator: Laura Van Gerven, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; AIT for airborn allergens (SCIT/SLIT); Diagnostic test: NAPT; NAPT test with airborn allergens ( HDM, Threes, Grasses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: s63711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No