Clinical Trial: Efficacy and Safety Evaluation in Recurrent Bronchospasms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Randomized Double-blind Placebo-controlled, Parallel, Single Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm for the Evaluati

Brief Summary: The purpose of the study is to evaluate the efficacy of a biological vaccine to prevent episodes of bronchospasm, induced by recurrent respiratory tract infections, in children, compared with a placebo group.

Detailed Summary: Double blind parallel placebo controlled study. The subjects will receive medication during 6 months and will be followed up during another six months.
Sponsor: Inmunotek S.L.

Current Primary Outcome: Recurrent bronchospasm [ Time Frame: 12 months ]

Reduction in the number of bronchospasms episodes compared with previous year


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Shortening of the severity of the bronchospasm episodes [ Time Frame: 12 months ]
  • Medication consumption [ Time Frame: 12 months ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
  • Direct costs [ Time Frame: 12 months ]
    Counting the: unscheduled visits to health center, emergency service visits, days of hospitalization and cost thereof, complementary tests, phone calls to the doctor or pediatrician per patient
  • Indirect costs [ Time Frame: 12 months ]
    Counting the: absenteeism from nursery, caregivers to the child at home and during hospital admissions per patient.


Original Secondary Outcome: Same as current

Information By: Inmunotek S.L.

Dates:
Date Received: November 16, 2012
Date Started: October 2012
Date Completion: May 2016
Last Updated: December 22, 2015
Last Verified: December 2015