NCT01500642|CompletedPhase 3
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Sponsor study identifier
interventional
45
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
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.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 2011
Actual (reported)September 2011
Actual (reported)December 22, 2011
Actual (reported)December 28, 2011
Actual (reported)To evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific (ragweed) in pre-seasonal SLIT vs oral-vestibular regimen and in pre-seasonal regimen of SLIT at 400 STU/dose vs 200 STU
3 months
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually
3 months
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
3 months
Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually
3 months
Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
3 months
15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001
15 patients treated with vestibular immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001
15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at doubled dose (400 STU / dose) from June to August 2001
slit one sublingual immunotherapy 200 stu
slit one vestibular immunotherapy 200 stu
Luigi Sacco Hospital
Milan, 20157, Italy
enrico iemoli, phd
luigi sacco hospital milano
45 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2011
First Posted
December 28, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
slit one 400 stu dose ragweed (sublingual doubled immunotherapy)
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Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
January 5, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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