Sponsor study identifier
interventional
18
1 country
1
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
August 25, 2005
Actual (reported)August 26, 2005
Actual (reported)January 2008
Actual (reported)October 2008
Actual (reported)Symptom and medication score recorded by subjects
Overall assessment of symptoms was recorded on a numeric scale (-3 to +3) by each patient at the end of the study
Assessment scores obtained after 12 months of treatment
Adverse events (conjunctival symptoms)
Conjunctival symptoms elicitation with P-pratense allergen (reduced response detection)
10 minutes post-conjunctival allergen provocation after 12 months of treatment
Intradermal allergen challenge
Biweekly during up-dosing and then monthly upto 6 months, and up to 12 months following initiation of treatment.
12 patients received active injections of an alum-adsorbed grass pollen vaccine
6 patients received placebo injections
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).
Placebo Injection
Royal Brompton Hospital, NHLI Imperial College
London, SW3 6LY, United Kingdom
Francis JN, James LK, Paraskevopoulos G, Wong C, Calderon MA, Durham SR, Till SJ. Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity. J Allergy Clin Immunol. 2008 May;121(5):1120-1125.e2. doi: 10.1016/j.jaci.2008.01.072. Epub 2008 Apr 18.
Stephen R Durham, Professor
Royal Brompton Hospital, Imperial College, National Heart & Lung Institute
18 participants (actual enrollment reported by the registry).
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
October 2002
Date type not reportedVenepuncture: 100ml blood sample taken on 12 separate visits
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
May 16, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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