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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01777438
First received: January 23, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition
Allergic Rhinitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Current Medication Use Three Years After Diagnosis of AR [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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



Enrollment: 434
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
patients having SCIT
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.

  Eligibility

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients who started immunotherapy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777438

Locations
Belgium
ORL
Leuven, Vlaams-Brabant, Belgium, 3000
UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Peter Hellings, MD UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777438     History of Changes
Other Study ID Numbers: 102012
Study First Received: January 23, 2013
Results First Received: August 14, 2013
Last Updated: October 24, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014