Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
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:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy|
- Current Medication Use Three Years After Diagnosis of AR [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]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 [ Time Frame: 3 years after diagnosis ] [ Designated as safety issue: No ]
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
|Study Start Date:||December 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777438
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Leuven, Vlaams-brabant, Belgium, 3000|
|Principal Investigator:||Peter Hellings, MD||UZ Leuven|