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
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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: NCT01486498

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

No publications provided

Responsible Party: Karin Dam Petersen, Associate Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT01486498     History of Changes
Other Study ID Numbers: SABAL
Study First Received: December 3, 2011
Last Updated: December 5, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Asthma
Conjunctivitis
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014