Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with at least 2 AR symptoms and a positive skin prick test for the 20 most prevalent inhalant allergens (house dust mites, grass pollen, tree pollen, animal dander, Alternaria, Penicillium and Cladosporium) in Belgium. 2. Moderate/severe and/or persistent AR according to ARIA guidelines 3. Age \> 18 and \< 60 years. 4. Written informed consent 5. Dutch, French or English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Current Medication Use Three Years After Diagnosis of AR | 3 years after starting SCIT | 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) |
| 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 years after diagnosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | 3 years after starting SCIT | 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 Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis | 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 |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period | 352 |
| Patients Having SCIT patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. | 82 |
| Total | 434 |
Baseline characteristics
| Characteristic | Control Group | Patients Having SCIT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 352 Participants | 82 Participants | 434 Participants |
| Region of Enrollment Belgium | 352 participants | 82 participants | 434 participants |
| Sex: Female, Male Female | 201 Participants | 48 Participants | 249 Participants |
| Sex: Female, Male Male | 151 Participants | 34 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 352 | 0 / 82 |
| serious Total, serious adverse events | 0 / 352 | 0 / 82 |
Outcome results
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)
Time frame: 3 years after starting SCIT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Current Medication Use Three Years After Diagnosis of AR | 61 percentage of participants |
| Patients Having SCIT | Current Medication Use Three Years After Diagnosis of AR | 29 percentage of participants |
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.
Time frame: 3 years after diagnosis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | 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 Score on a scale | Standard Deviation 2.8 |
| 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. | 2.5 Score on a scale | Standard Deviation 2.3 |
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
Time frame: 3 years after starting SCIT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | 63 percentage of participants |
| Patients Having SCIT | Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment | 84 percentage of participants |
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
Time frame: 3 years after diagnosis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis | 32 percentage of participants |
| Patients Having SCIT | Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis | 78 percentage of participants |