Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

Bronchospasm; Bronchitis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734811
• Other study ID #: MV130-SLG-002
• Secondary ID: 2012-002450-24
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: February 2017

Study information

• Verified date: October 2020
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Spasm
• Bronchiolitis
• Bronchitis
• Bronchospasm; Bronchiolitis
• Bronchospasm; Bronchitis
• Respiratory Sounds

Intervention

Biological:
• Biological vaccine
daily spray (2 puff of 100 µL) for six months

Locations

Country	Name	City	State
Spain	Hospital de Manises	Manises	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Inmunotek S.L.	Unidad de Investigacion Medica en Epidemiologia Clinica

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Alecsandru D, Valor L, Sánchez-Ramón S, Gil J, Carbone J, Navarro J, Rodríguez J, Rodríguez-Sainz C, Fernández-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of Health and Social Resources During the Whole Period of the Study.	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
Primary	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	12 months
Secondary	Duration (Days) of Wheezing Attacks (WA)	Review of bronchospasm (wheezing attacks) duration per patient	12 months
Secondary	Time Until Appearance of First WA	time (days) until appearance of first wheezing attack (WA)	12 months
Secondary	Number of Days With Wheezing Attacks During the Study	Review of the number of days with wheezing attacks during the study	12 months
Secondary	Number of Patients With Recurrent WA During the Study	Review of number of patients with recurrent WA during the whole study	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	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.	12 months