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Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life. Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so far.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | a control group of AR patients who visited the ear nose and throat (ENT) department of the University Hospitals Leuven in the same time period | ||
| patients having SCIT | patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. |
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| Measure | Description | Time Frame |
|---|---|---|
| Current Medication Use Three Years After Diagnosis of AR | Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group) | 3 years after starting SCIT |
| Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation. | Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points. | 3 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients | 3 years after starting SCIT |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
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patients who started immunotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hellings, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORL | Leuven | Vlaams-Brabant | 3000 | Belgium | ||
| UZ Leuven |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period |
| FG001 | Patients Having SCIT | patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period |
| BG001 | Patients Having SCIT | patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Current Medication Use Three Years After Diagnosis of AR | Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group) | Posted | Number | percentage of participants | 3 years after starting SCIT |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Hellings | UZ Leuven | +32 16 332338 | peter.hellings@uzleuven.be |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis |
ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis. Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR |
| 3 years after diagnosis |
| Leuven |
| Vlaams-brabant |
| 3000 |
| Belgium |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients | Posted | Number | percentage of participants | 3 years after starting SCIT |
|
|
|
| Primary | Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation. | Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points. | Posted | Mean | Standard Deviation | Score on a scale | 3 years after diagnosis |
|
|
|
| Secondary | Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis | ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis. Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR | Posted | Number | percentage of participants | 3 years after diagnosis |
|
|
|
| 0 |
| 352 |
| 0 |
| 352 |
| EG001 | Patients Having SCIT | patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. | 0 | 82 | 0 | 82 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |