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

NCT ID: NCT01777438

Last Updated: 2013-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

434 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

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

No interventions assigned to this group

patients having SCIT

patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.

No interventions assigned to this group

Eligibility Criteria

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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

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hellings, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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ORL

Leuven, Vlaams-Brabant, Belgium

Site Status

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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102012

Identifier Type: -

Identifier Source: org_study_id