At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
Biological vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm (Wheezing Attacks) for the Evaluation of Efficacy, Security and Clinical Impact.
In Brief
A Phase 3 clinical trial evaluating Biological vaccine for Bronchospasm; Bronchiolitis and Bronchospasm; Bronchitis. Completed, enrolled 120 participants across 2 sites.
Detailed Summary
The study will be conducted in two hospitals of the same geographic area. It will be included children \<3-years-old with recurrent wheezing attacks, confirmed by the review of the medical records, in the previous 12 months or a shorter time for those younger than one year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionMay 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedNov 28, 2012
Enrollment StartOct 1, 2012
Primary CompletionMay 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.6 years ago
Interventions
Biological vaccinebiological
daily spray (2 puff of 100 µL) for six months