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Grass Pollen Subcutaneous Immunotherapy in Elderly Patients

NCT02440243 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-05-12

No results posted yet for this study

Summary

Background There is limited evidence indicating that specific immunotherapy in elderly patients is safe and effective. This study was performed to evaluate the safety and efficacy of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients over 60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass pollen.

Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in elderly patients with SAR.

Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The patients were individually randomized to the active or placebo groups using a double-blinded method. There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V, Leiden, Netherlands) and 29 subjects in the placebo group monitored for three years. The patients were required to record each use of anti-allergy medication in a diary and use a visual graphic scale. The main outcome measure was the area under the curve (AUC) for the combined symptom and medication score (SMS).

Conditions

  • Allergy

Interventions

DRUG

Purethal

prerseasonal course of SCIT - three years

DRUG

Purethal -placebo

preseasonal course of SCIT - three years

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-09-30
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440243 on ClinicalTrials.gov