NCT01486498

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

4 years

First QC Date

December 3, 2011

Last Update Submit

December 5, 2011

Conditions

HypersensitivityAsthmaRhino-ConjunctivitisQuality of LifeEffects of Immunotherapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Allergic patients who had been immunotherapy treated before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Petersen KD, Kronborg C, Larsen JN, Dahl R, Gyrd-Hansen D. Patient related outcomes in a real life prospective follow up study: Allergen immunotherapy increase quality of life and reduce sick days. World Allergy Organ J. 2013 Sep 9;6(1):15. doi: 10.1186/1939-4551-6-15.

    PMID: 24229439DERIVED

MeSH Terms

Conditions

HypersensitivityAsthma

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Study Officials

  • Karin D Petersen, PhD

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 3, 2011

First Posted

December 6, 2011

Study Start

November 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12