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

Completed

• Conditions: Allergic Rhinitis

• Registration Number: NCT01777438
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2013-08-14
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-24
• Last Update Submitted: 2013-10-24
• Results First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

ORL; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-brabant, Belgium