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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karin Dam Petersen, Aalborg University
ClinicalTrials.gov Identifier:
NCT01486498
First received: December 3, 2011
Last updated: December 5, 2011
Last verified: December 2011

December 3, 2011
December 5, 2011
November 2005
November 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01486498 on ClinicalTrials.gov Archive Site
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Quality of Life and Health Economic Measurements in Allergic Patients Treated With Immunotherapy
Health Economic Analyses of Treatment Strategies for Allergic Respiratory Diseases

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)

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Hypersensitivity
  • Asthma
  • Rhino-Conjunctivitis
  • Quality of Life
  • Effects of Immunotherapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
571
November 2011
November 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01486498
SABAL
No
Karin Dam Petersen, Aalborg University
Aalborg University
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Study Chair: Karin D Petersen, PhD Associate Professor
Aalborg University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP