CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
subcutaneous immunotherapy with DPT extract +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01489020
NCT01489020Phase 1Completed
CompareCT.gov

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

Roxall Medicina España S.A·interventional·Posted Dec 9, 2011·Updated May 6, 2019

In Brief

A Phase 1 clinical trial evaluating subcutaneous immunotherapy with DPT extract and Subcutaneous depot placebo for Allergic Rhinoconjunctivitis. Completed, enrolled 48 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinoconjunctivitis
CountriesSpain
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2011
Enrollment StartJan 1, 2011
Primary CompletionJul 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.6 years ago

Interventions

subcutaneous immunotherapy with DPT extractbiological

Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

Subcutaneous depot placebobiological

Increasing doses of subcutaneous depot placebo in three different scales