An observational study in Allergic Rhinitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 2 sites in Belgium. Open to participants aged 19 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-17.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 434 is above the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients who started immunotherapy
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
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 who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
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)
Time frame: 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.
Time frame: 3 years after diagnosis
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
Time frame: 3 years after starting SCIT
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
Time frame: 3 years after diagnosis
| Milestone | Control Group | Patients Having SCIT |
|---|---|---|
| Started | 352 | 82 |
| Completed | 352 | 82 |
| Not completed | 0 | 0 |
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)
| percentage of participants | Control Group | Patients Having SCIT |
|---|---|---|
| Current Medication Use Three Years After Diagnosis of AR | 61 | 29 |
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
| percentage of participants | Control Group | Patients Having SCIT |
|---|---|---|
| Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | 63 | 84 |
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.
| Score on a scale | Control Group | Patients Having 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. | 3.7 ± 2.8 | 2.5 ± 2.3 |
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
| percentage of participants | Control Group | Patients Having SCIT |
|---|---|---|
| Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis | 32 | 78 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/352 (0%) | 0/352 (0%) |
| Patients Having SCIT | — | 0/82 (0%) | 0/82 (0%) |
| Age, Categorical(Participants) | Control Group | Patients Having SCIT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 352 | 82 | 434 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Control Group | Patients Having SCIT | Total |
|---|---|---|---|
| Female | 201 | 48 | 249 |
| Male | 151 | 34 | 185 |
| Region of Enrollment(participants) | Control Group | Patients Having SCIT | Total |
|---|---|---|---|
| Belgium | 352 | 82 | 434 |
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven