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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777438
• Other study ID #: 102012
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: October 24, 2013
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Locations

Country	Name	City	State
Belgium	ORL	Leuven	Vlaams-Brabant
Belgium	UZ Leuven	Leuven	Vlaams-brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 years after starting SCIT	No
Primary	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.	3 years after diagnosis	No
Secondary	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	3 years after starting SCIT	No
Secondary	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	3 years after diagnosis	No