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Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130)

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ClinicalTrials.gov Identifier: NCT01734811
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : January 15, 2018
Information provided by (Responsible Party):

Study Description
Brief 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, confirmed by the review of the medical records, in the previous 12 months or a shorter time for those younger than one year.

Condition or disease Intervention/treatment Phase
Bronchospasm; Bronchiolitis Bronchospasm; Bronchitis Biological: Biological vaccine Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm for the Evaluation of Efficacy, Security and Clinical Impact.
Study Start Date : October 2012
Primary Completion Date : May 2016
Study Completion Date : February 2017
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation
Biological: Biological vaccine
daily spray (2 puff of 100 µL) for six months
Experimental: Biological vaccine
The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation
Biological: Biological vaccine
daily spray (2 puff of 100 µL) for six months

Outcome Measures

Primary Outcome Measures :
  1. Recurrent bronchospasm [ Time Frame: 12 months ]
    Average reduction of bronchospasm episodes at 12 months. The number of bronchospasm episodes, in control and placebo group will be compared

Secondary Outcome Measures :
  1. Shortening of the bronchospasm episodes severity [ Time Frame: 12 months ]
    Review of bronchospasm episodes severity per patient

  2. Medication consumption [ Time Frame: 12 months ]
    Review of medication consumed from the beginning to the end of the bronchospam per patient

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
    Review of the number of adverse event per patient

  4. Health resource consumption [ Time Frame: 12 months ]
    Counting 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

  5. Social resouces [ Time Frame: 12 months ]
    Counting the absenteeism from nursery, caregivers to the child at home and during hospital admissions per patient.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734811

Hospital de Manises
Manises, Valencia, Spain, 46940
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Inmunotek S.L.
Unidad de Investigacion Medica en Epidemiologia Clinica
Study Director: Miguel Casanovas, PhD; MD
More Information

Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT01734811     History of Changes
Other Study ID Numbers: MV130-SLG-002
2012-002450-24 ( EudraCT Number )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Keywords provided by Inmunotek S.L.:

Additional relevant MeSH terms:
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Immunologic Factors
Physiological Effects of Drugs