- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734811
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130)
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46026
- Hospital Universitario y Politécnico La Fe
-
-
Valencia
-
Manises, Valencia, Spain, 46940
- Hospital de Manises
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation
|
daily spray (2 puff of 100 µL) for six months
|
EXPERIMENTAL: 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
|
daily spray (2 puff of 100 µL) for six months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration (Days) of Wheezing Attacks (WA)
Time Frame: 12 months
|
Review of bronchospasm (wheezing attacks) duration per patient
|
12 months
|
Time Until Appearance of First WA
Time Frame: 12 months
|
time (days) until appearance of first wheezing attack (WA)
|
12 months
|
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
|
12 months
|
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
|
12 months
|
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. |
12 months
|
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. |
12 months
|
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 |
12 months
|
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. |
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Miguel Casanovas, PhD; MD
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MV130-SLG-002
- 2012-002450-24 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchospasm; Bronchiolitis
-
Tampere UniversityOulu University Hospital; Kuopio University Hospital; Tampere University Hospital and other collaboratorsRecruitingBronchospasm; Bronchitis | Bronchitis Obstructive | Bronchiolitis; ObstructionFinland
-
Indiana University School of MedicineMerck Sharp & Dohme LLCWithdrawnExercise-Induced BronchospasmUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedExercise-induced BronchospasmUnited States
-
Ohio State UniversityCompleted
-
University of Kansas Medical CenterWithdrawn
-
University of New MexicoWithdrawnExercise-induced BronchospasmUnited States
-
SunovionCompletedExercise-induced BronchospasmUnited States
-
GlaxoSmithKlineCompletedBronchospasm | Activity/Exercise Induced BronchospasmUnited States
-
GlaxoSmithKlineCompletedBronchospasm | Activity/Exercise Induced BronchospasmUnited States
-
University of ArizonaGlaxoSmithKlineCompletedExercise Induced Bronchospasm, AsthmaUnited States
Clinical Trials on Biological vaccine
-
Mahidol UniversityBioNet-Asia Co., Ltd.Completed
-
Tongji UniversityShanghai Pharmaceuticals Holding Co., LtdActive, not recruitingAdvanced Hepatocellular CarcinomaChina
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Unknown
-
Valneva Austria GmbHCompletedChikungunya Virus InfectionUnited States
-
Green Cross CorporationUnknownWhooping Cough | Tetanus | DiphtheriaKorea, Republic of
-
BioNTech SEPfizerCompletedSARS-CoV-2 Infection, COVID-19United States, Spain, Finland, Poland, Mexico, Brazil
-
Lisata Therapeutics, Inc.Terminated
-
Talaris Therapeutics Inc.Northwestern UniversityNo longer availableRenal FailureUnited States
-
Institut du Cancer de Montpellier - Val d'AurelleRecruiting
-
Nykode Therapeutics ASATheradex; Vaccibody ASCompletedHigh Grade Cervical Intraepithelial NeoplasiaGermany