A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Sublingual Immunotherapy (SLIT) in Adults Sensitized to the Standardized Allergenic Extract, Cat Hair (Felis Domesticus)

NCT00689299 Phase 2 COMPLETED Results posted

The purpose of this study is to identify an effective dose of allergen-specific immunotherapy for cat hair (Felis domesticus) administered by the oral/sublingual route.

Details

Lead sponsor	Antigen Laboratories, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	167
Start date	2008-10
Completion	2009-06

Conditions

• Allergy

Interventions

• Standardized Allergenic Extract, Cat Hair
• Placebo

Primary outcomes

• Scores on a Scale (Average of Total Symptom Scores) — 20 weeks
  Sum of individual symptoms scores, 7 items, 21 points maximum Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat. Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures.

Countries

United States