Clinical Trial: A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Brief Summary: The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Detailed Summary:
Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.
The study has been designed as an open trial which will be conducted in 4 Spanish sites.
Sponsor: Roxall Medicina España S.A
Current Primary Outcome: Number and severity of adverse reactions as a measure of Safety and tolerability [ Time Frame: across 17 weeks treatment period ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Immunoglobulin changes from baseline [ Time Frame: At baseline and 1 week after last administered dose ]
- Skin reactivity changes from baseline [ Time Frame: At baseline and 1 week after last administered dose ]
Original Secondary Outcome: Same as current
Information By: Roxall Medicina España S.A
Dates:
Date Received: June 1, 2015
Date Started: May 2015
Date Completion:
Last Updated: April 28, 2017
Last Verified: April 2017
