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

This study is currently recruiting participants.
Verified May 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01777438
First received: January 23, 2013
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  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 SCIT or SLIT on the long term has not yet been investigated so far.


Condition
Patients Who Started Immunotherapy

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:
  • evaluation of the effect of SCIT [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]

    Evaluation of the effect of subcutaneous immunotherapy (SCIT) on

    • current control of AR (using VAS for total nasal symptom score, TNS)
    • total and individual nasal symptom severity (using VAS for 5 individual nasal symptoms)
    • medication use in AR at three years after starting SCIT


Secondary Outcome Measures:
  • evaluation of the success of IT based on control of AR in relation to sensitization pattern [ Time Frame: 3 years after starting SCIT ] [ Designated as safety issue: No ]
    - evaluation of the success of IT based on control of AR in relation to sensitization pattern (mono- vs polysensitized; sensitization to house dust mite vs pollen)


Estimated Enrollment: 240
Study Start Date: December 2012
Estimated 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777438

Contacts
Contact: valerie droessaert, bachelor valerie.droessaert@uzleuven.be
Contact: peter hellings, MD peter.hellings@uzleuven.be

Locations
Belgium
ORL Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Emily Dekimpe, Msc         emily.dekimpe@uzleuven.be    
Principal Investigator: Hellings Peter, MD            
UZ Leuven Not yet recruiting
Leuven, Vlaams-brabant, Belgium, 3000
Contact: emily dekimpe, Msc         emily.dekimpe@uzleuven.be    
Principal Investigator: peter hellings, MD            
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
Last Updated: May 21, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013