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| Name | Class |
|---|---|
| AZ Sint-Jan AV | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIT | Drug | AIT for airborn allergens (SCIT/SLIT) |
| |
| 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. |
| Measure | Description | 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. |
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Inclusion Criteria:
OR suspected local allergic rhinitis
Exclusion Criteria:
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Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margot Vandekerckhove | Contact | +3216332342 | margot.vandekerckhove@uzleuven.be | |
| Laura Van Gerven, PhD | Contact | +3216336340 | laura.vangerven@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Vlaam Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| NAPT |
| Diagnostic Test |
NAPT test with airborn allergens ( HDM, Threes, Grasses) |
|
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 |
| 3 year |
| AZ Sint-Jan | Not yet recruiting | Bruges | 8000 | Belgium |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |