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Efficacy and Safety Evaluation in Recurrent Bronchospasms (MV130)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 13, 2014
Last verified: March 2014
  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: Biological vaccine
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.

Resource links provided by NLM:


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 subjects will receive daily dose of the biological vaccine during 6 months
Biological: Biological vaccine
Daily dose
Experimental: Biological vaccine
The subjects will receive daily dose of the biological vaccine during 6 months
Biological: Biological vaccine
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 de Manises Active, not recruiting
Manises, Valencia, Spain, 46940
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: March 13, 2014
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 November 20, 2014