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

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ClinicalTrials.gov Identifier: NCT01486498
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hypersensitivity Asthma Rhino-Conjunctivitis Quality of Life Effects of Immunotherapy

Study Design

Study Type : Observational
Actual Enrollment : 571 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Health Economic Analyses of Treatment Strategies for Allergic Respiratory Diseases
Study Start Date : November 2005
Primary Completion Date : November 2009
Study Completion Date : November 2011
Groups and Cohorts

Outcome Measures

Eligibility Criteria

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.

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
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 Posted: December 6, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

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