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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
Hospital Germans Triasl i Pujol
Badalona, Barcelona, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital de Valdecilla
Santander, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
Incidence of Treatment-Emergent Adverse Events
Time frame: From date inform consent is signed until the date the treatment is completed, assessed up to 5 months
Immunoglobulin level changes
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Skin prick test reactivity
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
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