|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 November 2021 |
|
Main ID: |
NCT01734811 |
|
Date of registration:
|
16/11/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
MV130 |
|
Scientific 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. |
|
Date of first enrolment:
|
October 2012 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01734811 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Miguel Casanovas, PhD; MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion 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
Age minimum:
12 Months
Age maximum:
36 Months
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Bronchospasm; Bronchiolitis
|
|
Bronchospasm; Bronchitis
|
|
Intervention(s)
|
|
Biological: Biological vaccine
|
|
Primary Outcome(s)
|
|
Number of Recurrent Bronchospasm (Wheezing Attacks)
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Medication Score During WA
[Time Frame: 12 months]
|
|
Overall Medication Score
[Time Frame: 12 months]
|
|
Duration (Days) of Wheezing Attacks (WA)
[Time Frame: 12 months]
|
|
Overall Symptom Score
[Time Frame: 12 months]
|
|
Number of Days With Wheezing Attacks During the Study
[Time Frame: 12 months]
|
|
Symptom Score During Wheezing Attacks
[Time Frame: 12 months]
|
|
Number of Patients With Recurrent WA During the Study
[Time Frame: 12 months]
|
|
Time Until Appearance of First WA
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
2012-002450-24
|
|
MV130-SLG-002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|