Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy

Conditions
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Allergic Rhinitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Moderate/severe and/or persistent AR according to ARIA guidelines Age > 18 and < 60 years. Written informed consent Dutch, French or English speaking patients Exclusion Criteria: Exclusion criteria Age < 18 and > 60 years Patients with mild AR Patients not being able to give an informed consent Patients being enrolled in other clinical trials No knowledge of Dutch, French or English

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>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<br>patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |