30
Participants
Start Date
November 30, 2005
Primary Completion Date
December 31, 2008
Study Completion Date
December 31, 2008
(agent for immunotherapy) Staloral
"Immunotherapy agent for sublingual daily use. First week (vial containing the concentration 10 IR/ml) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures~Second week (300 IR/ml) (vial containing the concentration 300 IR/ml) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures~Maintenance phase Day 12 to 364 - 8 pressures daily~The first year will be followed by a second year open label period (optional)- 8 pressures daily"
Placebo
"Matching placebo for sublingual use. Same schedule used for the intervention ACTIVE group.~First week (vial containing placebo) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures~Second week (300 IR/ml) (vial containing placebo) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures~Maintenance phase Day 12 to 364 - 8 pressures daily"
The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine, Melbourne
Lead Sponsor
Bayside Health
OTHER_GOV