Bronchospasm; BronchiolitisPhase 3MV130NCT01734811
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
A Phase 3 study testing Biological vaccine in people with Bronchospasm; Bronchiolitis and Bronchospasm; Bronchitis, run by Inmunotek S.L. at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Bronchospasm; Bronchiolitis, Bronchospasm; Bronchitis
- What is being tested?
- Biological vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2012to Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de Manises
Manises, Valencia, 46940
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
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.
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.
Read the 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.
- Being tested
- Biological vaccine
- Keywords
- Vaccine, Bronchospasm
- Medical subject headings
- Bronchial Spasm, Bronchiolitis, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological vaccineBiological
daily spray (2 puff of 100 µL) for six months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Biological vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (8)
Duration (Days) of Wheezing Attacks (WA)
Review of bronchospasm (wheezing attacks) duration per patient
Measured: 12 months
Time Until Appearance of First WA
time (days) until appearance of first wheezing attack (WA)
Measured: 12 months
Number of Days With Wheezing Attacks During the Study
Review of the number of days with wheezing attacks during the study
Measured: 12 months
Number of Patients With Recurrent WA During the Study
Review of number of patients with recurrent WA during the whole study
Measured: 12 months
Symptom Score During Wheezing Attacks
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.
Measured: 12 months
Medication Score During WA
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.
Measured: 12 months
Overall Symptom Score
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
Measured: 12 months
Overall Medication Score
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchospasm; BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unidad de Investigacion Medica en Epidemiologia Clinica
- Responsible party
- Sponsor
- Investigators
- Miguel Casanovas, PhD; MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734811
- Sponsor's protocol ID
- MV130-SLG-002
- Other IDs
- 2012-002450-24
- Acronym
- MV130
- Status last verified
- Oct 2020
- First submitted
- 16 Nov 2012
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 21391984Nieto 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.
PubMed 33705665
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01734811
- Acronym / sponsor ID
- MV130 / MV130-SLG-002
- Keywords
- Vaccine, Bronchospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Collaborators
- Unidad de Investigacion Medica en Epidemiologia Clinica
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Biological vaccineThe subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation |
| Biological vaccine | Experimental | Biological: Biological vaccineThe subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological vaccinedaily spray (2 puff of 100 µL) for six months | Biological | Biological vaccine, Placebo |
Primary outcome
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
8 secondary outcomes
Duration (Days) of Wheezing Attacks (WA)
Time frame: 12 months
Time Until Appearance of First WA
Time frame: 12 months
Number of Days With Wheezing Attacks During the Study
Time frame: 12 months
Number of Patients With Recurrent WA During the Study
Time frame: 12 months
Symptom Score During Wheezing Attacks
Time frame: 12 months
Medication Score During WA
Time frame: 12 months
Overall Symptom Score
Time frame: 12 months
Overall Medication Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21391984Alecsandru 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.
- Derived from this study: PubMed 33705665Nieto 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Casanovas, PhD; MD study director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biological vaccine in people with Bronchospasm; Bronchiolitis and Bronchospasm; Bronchitis, run by Inmunotek S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Recurrent Bronchospasm (Wheezing Attacks) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.