Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 434
- Locations
- 2
- Primary Endpoint
- Current Medication Use Three Years After Diagnosis of AR
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Current Medication Use Three Years After Diagnosis of AR
Time Frame: 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.
Time Frame: 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 Outcomes
- Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment(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(3 years after diagnosis)