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Efficacy and Safety Evaluation in Recurrent Bronchospasms (MV130)

This study is currently recruiting participants.
Verified April 2013 by Inmunotek S.L.
Sponsor:
Collaborator:
Unidad de Investigacion Medica en Epidemiologia Clinica
Information provided by (Responsible Party):
Inmunotek S.L.
ClinicalTrials.gov Identifier:
NCT01734811
First received: November 16, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Bronchospasm
 Biological: Bactek
Biological: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double-blind Placebo-controlled, Parallel, Single Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm for the Evaluation of Efficacy, Security and Clinical Impact.

Further study details as provided by Inmunotek S.L.:

Primary Outcome Measures:
  • Recurrent bronchospasm [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reduction in the number of bronchospasms episodes compared with previous year


Secondary Outcome Measures:
  • Shortening of the severity of the bronchospasm episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Medication consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Direct costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Counting the: absenteeism from nursery, caregivers to the child at home and during hospital admissions per patient.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The subject of this arm will receive daily placebo dose during 6 months
 Biological: Placebo
Daily dose
Experimental: Bactek
The subjects will receive daily dose of the biological vaccine during 6 months
 Biological: Bactek
Daily dose

Detailed Description:

Double blind parallel placebo controlled study. The subjects will receive medication during 6 months and will be followed up during another six months.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects whose parents /legal representative have given written informed consent.
  • Both gender
  • Subject up to 36 months of age.
  • Subjects with recurrent bronchospasms ; 3 or more exacerbations in the last 12 months

Exclusion Criteria:

  • Subjects whose parents/legal representative have not given written informed consent.
  • Subjects out of aged range
  • Subjects with malignancies or chemotherapy treatment
  • Subjects included in another clinical trial in the last 12 months.
  • Subject in immunosuppressive or immunostimulatory treatment
  • Subjects who have received iv gamma globulin in the past 12 months.
  • Subjects diagnosed with candidiasis or fungal recurrent infections.
  • Subjects diagnosed with malabsorption syndrome
  • Subjects with clinical allergy to common aeroallergens in the geographical area.
  • Subjects with hepatitis virus infections, HIV and tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734811

Contacts
Contact: Antonio Nieto, PhD; MD 34961244378 nieto_ant@gva.es
Contact: Miguel Casanovas, PhD; MD 34916510010 mcasanovas@inmunotek.com

Locations
Spain
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain, 46026
Contact: Antonio Nieto, PhD; MD     34961244378     nieto_ant@gva.es    
Contact: Miguel Casanovas, PhD; MD     34916510010     mcasanovas@inmunotek.com    
Principal Investigator: Antonio Nieto, PhD; MD            
Sponsors and Collaborators
Inmunotek S.L.
Unidad de Investigacion Medica en Epidemiologia Clinica
Investigators
Study Director: Miguel Casanovas, PhD; MD
  More Information

No publications provided

Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT01734811     History of Changes
Other Study ID Numbers: MV130-SLG-002, 2012-002450-24
Study First Received: November 16, 2012
Last Updated: April 22, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Inmunotek S.L.:
Vaccine
Bronchospasm

Additional relevant MeSH terms:
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013