Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

NCT ID: NCT01734811

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-02-28

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.

Conditions

Bronchospasm; Bronchiolitis; Bronchospasm; Bronchitis

Keywords

Vaccine; Bronchospasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Biological vaccine

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

Biological vaccine

Intervention Type: BIOLOGICAL

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

Interventions

Biological vaccine

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidad de Investigacion Medica en Epidemiologia Clinica

OTHER

Sponsor Role: collaborator

Inmunotek S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Casanovas, PhD; MD

Role: STUDY_DIRECTOR

Locations

Hospital de Manises

Manises, Valencia, Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21391984 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33705665 (View on PubMed)

Other Identifiers

2012-002450-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MV130-SLG-002

Identifier Type: -

Identifier Source: org_study_id