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

Universitaire Ziekenhuizen KU Leuven434 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

434

Conditions

Allergic Rhinitis

Eligibility

Sex: ALLMin age: 19 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: Exclusion criteria 1. Age \< 18 and \> 60 years 2. Patients with mild AR 3. Patients not being able to give an informed consent 4. Patients being enrolled in other clinical trials 5. No knowledge of Dutch, French or English

Locations (2)

ORL

Leuven, Vlaams-Brabant, Belgium

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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