Clinical trial NCT01734811: Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchospasm; Bronchiolitis
Bronchospasm; Bronchitis
Keywords: Vaccine
Bronchospasm
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
Collaborators: name: Unidad de Investigacion Medica en Epidemiologia Clinica
First posted: 2012-11-28
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Recurrent Bronchospasm (Wheezing Attacks)
timeFrame: 12 months
Secondary outcomes:
measure: Duration (Days) of Wheezing Attacks (WA)
timeFrame: 12 months
measure: Time Until Appearance of First WA
timeFrame: 12 months
measure: Number of Days With Wheezing Attacks During the Study
timeFrame: 12 months
measure: Number of Patients With Recurrent WA During the Study
timeFrame: 12 months
measure: Symptom Score During Wheezing Attacks
timeFrame: 12 months
measure: Medication Score During WA
timeFrame: 12 months
measure: Overall Symptom Score
timeFrame: 12 months
measure: Overall Medication Score
timeFrame: 12 months
Other outcomes:
measure: Use of Health and Social Resources During the Whole Period of the Study.
timeFrame: 12 months
Locations:
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
name: Miguel Casanovas, PhD; MD
role: STUDY_DIRECTOR
References:
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.
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.