A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
Sponsor study identifier
interventional
52
1 country
5
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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 polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)June 2016
Actual (reported)July 22, 2016
Actual (reported)July 29, 2016
Actual (reported)Number and severity of adverse reactions as a measure of safety and tolerabitity
Across 12-15 weeks treatment period
Immunoglobulin changes from baseline
At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
At baseline and 1 week after last administered dose
Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day.
Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached.
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital de Zafra
Zafra, Badajoz, 06300, Spain
Hospital de Henares
Henares, Madrid, Spain
Hospital Clínico Granada
Granada, 18012, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
María C Gómez, Dr.
Roxall Medicina España S.A
52 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2016
First Posted
July 29, 2016
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
May 1, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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