NCT01489020

Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Roxall Medicina España S.A · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	subcutaneous immunotherapy with DPT extract	Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
BIOLOGICAL	Subcutaneous depot placebo	Increasing doses of subcutaneous depot placebo in three different scales

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2011-12-09
• Last updated: 2019-05-06
• Results posted: 2019-05-06

Locations

2 sites across 1 country: Spain