Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135629
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2005-08-25
Brief Title:
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever A Pilot Study Up-dosing Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 100000 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
Detailed Description:
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 100000 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 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None