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Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130)

Primary Purpose

Bronchospasm; Bronchiolitis, Bronchospasm; Bronchitis

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Biological vaccine
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchospasm; Bronchiolitis focused on measuring Vaccine, Bronchospasm

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Manises
  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Biological vaccine

Arm Description

The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation

The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation

Outcomes

Primary Outcome Measures

Number of Recurrent Bronchospasm (Wheezing Attacks)
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

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2012
Last Updated
November 4, 2021
Sponsor
Inmunotek S.L.
Collaborators
Unidad de Investigacion Medica en Epidemiologia Clinica
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1. Study Identification

Unique Protocol Identification Number
NCT01734811
Brief Title
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
Acronym
MV130
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.
Collaborators
Unidad de Investigacion Medica en Epidemiologia Clinica

4. Oversight

Data Monitoring Committee
No

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchospasm; Bronchiolitis, Bronchospasm; Bronchitis
Keywords
Vaccine, Bronchospasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation
Arm Title
Biological vaccine
Arm Type
Experimental
Arm Description
The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation
Intervention Type
Biological
Intervention Name(s)
Biological vaccine
Intervention Description
daily spray (2 puff of 100 µL) for six months
Primary Outcome Measure Information:
Title
Number of Recurrent Bronchospasm (Wheezing Attacks)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Duration (Days) of Wheezing Attacks (WA)
Description
Review of bronchospasm (wheezing attacks) duration per patient
Time Frame
12 months
Title
Time Until Appearance of First WA
Description
time (days) until appearance of first wheezing attack (WA)
Time Frame
12 months
Title
Number of Days With Wheezing Attacks During the Study
Description
Review of the number of days with wheezing attacks during the study
Time Frame
12 months
Title
Number of Patients With Recurrent WA During the Study
Description
Review of number of patients with recurrent WA during the whole study
Time Frame
12 months
Title
Symptom Score During Wheezing Attacks
Description
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.
Time Frame
12 months
Title
Medication Score During WA
Description
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.
Time Frame
12 months
Title
Overall Symptom Score
Description
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
Time Frame
12 months
Title
Overall Medication Score
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Use of Health and Social Resources During the Whole Period of the Study.
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Casanovas, PhD; MD
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21391984
Citation
Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.
Results Reference
background
PubMed Identifier
33705665
Citation
Nieto A, Mazon A, Nieto M, Calderon R, Calaforra S, Selva B, Uixera S, Palao MJ, Brandi P, Conejero L, Saz-Leal P, Fernandez-Perez C, Sancho D, Subiza JL, Casanovas M. Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Aug 15;204(4):462-472. doi: 10.1164/rccm.202003-0520OC.
Results Reference
derived

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Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

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