NCT01591343

Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml), to Treat Allergic Rhinitis or Rhinoconjunctivitis With or Without Asthma

Prospective Study to Evaluate the Safety of a 4-month Treatment With Depigoid® Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml) in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Mild Persistent or Intermittent Asthma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma. Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.

Detailed description

Investigator(s): Approximately 10 study centers (allergy services) in Spain Planned study period: MAY 2012 (first subject in) - MAR 2013 (last subject out) Objectives: Primary objective: to evaluate the safety of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen. Secondary objective: to assess the subjects' immunologic responses to the above treatment. Study design: This is a prospective, non-randomized, uncontrolled, open-label safety study. When the first 29 subjects have completed the study, an interim analysis will be conducted to check whether the number of systemic reactions in these subjects is below a predefined limit. Planned number of subjects: 103 subjects in total. Medical condition or disease under investigation: Allergic rhinitis or rhinoconjunctivitis, with or without mild persistent or intermittent asthma. Test product, dose and mode of administration: Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection Duration of treatment: 16 weeks. Criteria for evaluation: Safety: Local and systemic adverse reactions (EAACI classification); adverse events. Efficacy: Immunologic response to the treatment. Statistical methods: Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period. Analysis of primary variable: exact binomial test

Conditions

• Allergic Rhinitis
• Rhinoconjunctivitis
• Mild Persistent Asthma
• Mild Intermittent Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Depigoid® (500 DPP/ml)	Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-05-04
• Last updated: 2018-02-23

Locations

10 sites across 1 country: Spain