NCT01734811

Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized, double-blind, placebo-controlled, parallel-group study will included 120 children \<3 years old with ≥3 episodes of wheezing during the previous year. They will receive active treatment or placebo for six months. The main outcome will be the number of wheezing attacks during one year. Other outcomes were duration and severity of wheezing attacks , symptom and medication scores, and use of health resources.

Conditions

• Bronchospasm; Bronchiolitis
• Bronchospasm; Bronchitis

Interventions

Type	Name	Description
BIOLOGICAL	Biological vaccine	daily spray (2 puff of 100 µL) for six months

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-05-01
• Completion: 2017-02-01
• First posted: 2012-11-28
• Last updated: 2021-11-08
• Results posted: 2020-09-04

Locations

2 sites across 1 country: Spain