Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130)

November 4, 2021 updated by: Inmunotek S.L.

Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm (Wheezing Attacks) for the Evaluation of Efficacy, Security and Clinical Impact.

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (wheezing attacks); 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Recurrent Bronchospasm (Wheezing Attacks)
Time Frame: 12 months
Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration (Days) of Wheezing Attacks (WA)
Time Frame: 12 months
Review of bronchospasm (wheezing attacks) duration per patient
12 months
Time Until Appearance of First WA
Time Frame: 12 months
time (days) until appearance of first wheezing attack (WA)
12 months
Number of Days With Wheezing Attacks During the Study
Time Frame: 12 months
Review of the number of days with wheezing attacks during the study
12 months
Number of Patients With Recurrent WA During the Study
Time Frame: 12 months
Review of number of patients with recurrent WA during the whole study
12 months
Symptom Score During Wheezing Attacks
Time Frame: 12 months

Total of Symptom score during wheezing attacks. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.

Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.

The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.

The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.

12 months
Medication Score During WA
Time Frame: 12 months

Review of medication consumption during wheezing attacks. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.

Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.

The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.

12 months
Overall Symptom Score
Time Frame: 12 months

Review of symptoms during the whole study. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.

Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.

The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.

The total symptom score was calculated as the sum of all individual scores during the whole study

12 months
Overall Medication Score
Time Frame: 12 months

Review of medication consumption during the whole study. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.

Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.

The total symptom score was calculated as the sum of all individual scores during the whole study.

12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Health and Social Resources During the Whole Period of the Study.
Time Frame: 12 months

The use of health and social resources during the study was also recorded: days of hospitalization in ward and/or intensive care unit, visits to the emergency units, unscheduled visits to the pediatrician and/or to the specialist, telephone calls to the pediatrician, complementary tests (chest radiogram, blood analysis, others), days of school absenteeism and caregiver-days when the children needed them. The data were obtained from the diary cards and confirmed through the review of medical records.

Maximum value corresponds to the maximum days spent in health resources (specified above) and the minimum value corresponds to the minimum of days spent in health resources (specified above)

12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Miguel Casanovas, PhD; MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

October 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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