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Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites

Allergic Rhinoconjunctivitis Clinical Trial

Official title:
An Open, Multicenter Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House

Clinical Trial Summary

The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites.

Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites

Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity

Clinical Trial Description

The aim of present clinical trial is to go deeper into the safety of the vaccine of mixture of DPT and DF (50:50). Although this is the first clinical trial to date to be performed with this vaccine, there have been two clinical trials with the same formulation and DPT 100% as active ingredient( NºEudraCT: 2009-016277-15 and NºEudraCT: 2011-004583-30). Given that there is a remarkable cross-reactivity between the DPT and DF mites, the results of the two clinical trials conducted to date with subcutaneous depot vaccine with Dermatophagoides pteronyssinus 100% extract mite, are very significant ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02881879
Study type Interventional
Source Roxall Medicina España S.A
Contact
Status Completed
Phase Phase 1
Start date July 2016
Completion date September 2017
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