A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Allergic RhinitisAsthma
Interventions
DRUG

(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"

DRUG

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"

Trial Locations (1)

3181

The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayside Health

OTHER_GOV