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Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

NCT01734811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-11-08

Study results available
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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.

Conditions

  • Bronchospasm; Bronchiolitis
  • Bronchospasm; Bronchitis

Interventions

BIOLOGICAL

Biological vaccine

daily spray (2 puff of 100 µL) for six months

Sponsors & Collaborators

  • Unidad de Investigacion Medica en Epidemiologia Clinica

    collaborator OTHER

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Miguel Casanovas, PhD; MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-05-31
Completion
2017-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01734811 on ClinicalTrials.gov