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

NCT02881879 Phase 1 COMPLETED

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

Details

Lead sponsor	Roxall Medicina España S.A
Phase	Phase 1
Status	COMPLETED
Enrolment	43
Start date	2016-07
Completion	2017-09

Conditions

• Allergic Rhinoconjunctivitis

Interventions

• Allergovac depot DPT/DF (50:50)

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events — From date inform consent is signed until the date the treatment is completed, assessed up to 5 months

Countries

Spain