Local Allergic Rhinitis, Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis
Conditions
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
Interventions
DRUGAIT
AIT for airborn allergens (SCIT/SLIT)
DIAGNOSTIC_TESTNAPT
NAPT test with airborn allergens ( HDM, Threes, Grasses)
Sponsors
Universitaire Ziekenhuizen KU Leuven
AZ Sint-Jan AV
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE . | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
Secondary
| 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 |
Countries
Belgium
Contacts
CONTACTMargot Vandekerckhove
CONTACTLaura Van Gerven, PhD
Outcome results
None listed