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

December 5, 2011 updated by: Karin Dam Petersen, Aalborg University

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)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Investigators

  • Study Chair: Karin D Petersen, PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 3, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SABAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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