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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ORL, Leuven, Vlaams-Brabant, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jan 28, 2013
Registry last updated: Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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