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Quality of Life and Health Economic Measurements in Allergic Patients Treated With Immunotherapy (SABAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486498
First Posted: December 6, 2011
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karin Dam Petersen, Aalborg University
  Purpose
Grass pollen and house dust mites (HDM) are the most common allergens causing allergic rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect of SCIT on disease severity classifications in terms of number of days affected- and sick days on patients with grass pollen and/or HDM induced disease. These outcome measures will be gathered in one single measure: Quality Adjusted Life Years (QALY)

Condition
Hypersensitivity Asthma Rhino-Conjunctivitis Quality of Life Effects of Immunotherapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Health Economic Analyses of Treatment Strategies for Allergic Respiratory Diseases

Further study details as provided by Karin Dam Petersen, Aalborg University:

Enrollment: 571
Study Start Date: November 2005
Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The intervention group consisted of 254 patients receiving subcutaneous allergen specific immunotherapy (SCIT) with grass pollen and/or house dust mite extracts. The control group consisted of 317 patients with grass pollen and/or house dust mite allergy, who were not receiving SCIT.
Criteria

Inclusion Criteria:

  • Adults (> 16 years) and allergic to grass pollen and/or house dust mites.

Exclusion Criteria:

  • Allergic patients who had been immunotherapy treated before.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486498


Sponsors and Collaborators
Aalborg University
Investigators
Study Chair: Karin D Petersen, PhD Associate Professor
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karin Dam Petersen, Associate Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT01486498     History of Changes
Other Study ID Numbers: SABAL
First Submitted: December 3, 2011
First Posted: December 6, 2011
Last Update Posted: December 6, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Immune System Diseases
Conjunctival Diseases
Eye Diseases