NCT00987909

Exposure Chamber Trial With Cat Immunotherapy

A Phase II Trial Assessing the Tolerability and Pharmacodynamic Effect of US SLIT Cat Hair in Subject With Cat Allergy and Investigating Efficacy Variables in an Environmental Exposure Chamber Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.

Conditions

• Cat Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Specific allergen immunotherapy (placebo)	Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks
BIOLOGICAL	Specific allergen immunotherapy	Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks.
BIOLOGICAL	Specific allergen immunotherapy	Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks
BIOLOGICAL	Specific allergen immunotherapy	Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2009-10-01
• Last updated: 2010-08-18

Locations

1 site across 1 country: Canada