Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

NCT01734811 | Completed Phase 3 Results

• 2 other identifiers: MV130-SLG-0022012-002450-24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchospasm; Bronchiolitis; Bronchospasm; Bronchitis

Keywords

Vaccine; Bronchospasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Duration (Days) of Wheezing Attacks (WA)

  12 months

• Time Until Appearance of First WA

  12 months

• Number of Days With Wheezing Attacks During the Study

  12 months

• Number of Patients With Recurrent WA During the Study

  12 months

• Symptom Score During Wheezing Attacks

  12 months

Other Outcomes (1)

• Use of Health and Social Resources During the Whole Period of the Study.

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Biological: Biological vaccine

Biological vaccine

EXPERIMENTAL

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

Biological: Biological vaccine

Interventions

Biological vaccine BIOLOGICAL

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

Biological vaccine; Placebo

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inmunotek S.L.: lead
• Unidad de Investigacion Medica en Epidemiologia Clinica: collaborator

Study Sites (2)

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Related Publications (2)

• 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.

  PMID: 21391984 BACKGROUND

• 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.

  PMID: 33705665 DERIVED

MeSH Terms

Conditions

Bronchial Spasm; Bronchiolitis; Bronchitis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Inmunotek

mcasanovas@inmunotek.com

916 510 010

Study Officials

• Miguel Casanovas, PhD; MD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 28, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 8, 2021
• Results First Posted: September 4, 2020

Record last verified: 2020-10

Locations

ES (2)