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Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever: A Pilot Study. (Up-dosing Study)
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.
This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was 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. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Royal Brompton Hospital, NHLI Imperial College
London, United Kingdom
Start Date
October 1, 2002
Primary Completion Date
January 1, 2008
Completion Date
October 1, 2008
Last Updated
May 16, 2024
18
ACTUAL participants
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).
BIOLOGICAL
Placebo Injection
OTHER
Venepuncture: 100ml blood sample taken on 12 separate visits
PROCEDURE
Lead Sponsor
Imperial College London
Collaborators
NCT00127647
NCT00406783
Data Source & Attribution
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