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Completed

NCT Number: NCT01734811

Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

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.

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Key information

Conditions

Bronchospasm; Bronchiolitis Bronchial Diseases Bronchial Spasm Bronchiolitis Bronchitis Bronchospasm; Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Manises, Manises, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological vaccine

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration (Days) of Wheezing Attacks (WA)

    Time frame: 12 months

    Review of bronchospasm (wheezing attacks) duration per patient

  2. Time Until Appearance of First WA

    Time frame: 12 months

    time (days) until appearance of first wheezing attack (WA)

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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.

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Collaborators

  • Unidad de Investigacion Medica en Epidemiologia Clinica

Registry information

Official study 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.

Acronym: MV130

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 28, 2012
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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