NCT00689299

Phase 2 Study in Adults Sensitized to Cat

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Antigen Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This was a phase 2, randomized, double-blind, placebo-controlled, parallel groups study conducted in 3 centers in the US (NCT00689299). Study drug was sublingually dosed once daily as 0.15 mL of US standardized cat hair extract dosed either undiluted, as 1:10 dilution, or placebo. Target dose was obtained on Day 3 of dose titration escalating through 1:100 and 1:10 dilutions on Day 1 and Day 2 in the high dose group or placebo and 1:100 dilutions in the low dose group. Treatment duration was 20 weeks. Adult (\>18 years) study subjects had positive history for cat allergy without asthma, positive skin test to cat allergen, absence of immunotherapy during the prior 2 years, and absence of other confounding baseline conditions. The primary outcome parameter was average Total Symptom Score (TSS) during a 1-hour cat chamber exposure. TSS is the sum of 7 items rated from 0 - 3 (none to severe) for nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) and non-nasal symptoms (eye watering, eye itching, and itching palate/ ear/ throat).

Conditions

• Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Standardized Allergenic Extract, Cat Hair	Standardized Cat Hair Allergenic Extract sublingual drops
BIOLOGICAL	Placebo	Placebo Sublingual Drops

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2008-06-03
• Last updated: 2014-05-01
• Results posted: 2014-04-07

Locations

3 sites across 1 country: United States