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Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever

NCT00135629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-16

No results posted yet for this study

Summary

The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

BIOLOGICAL

Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).

Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).

OTHER

Placebo Injection

Placebo Injection

PROCEDURE

Venepuncture: 100ml blood sample taken on 12 separate visits

Venepuncture: 100ml blood sample taken on 12 separate visits

Sponsors & Collaborators

  • ALK-Abelló A/S

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Stephen R Durham, Professor · Royal Brompton Hospital, Imperial College, National Heart & Lung Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2008-01-31
Completion
2008-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT00135629 on ClinicalTrials.gov