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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002450-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Unidad de Investigacion Medica en Epidemiologia Clinica | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological vaccine | Biological | daily spray (2 puff of 100 µL) for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration (Days) of Wheezing Attacks (WA) | Review of bronchospasm (wheezing attacks) duration per patient | 12 months |
| Time Until Appearance of First WA | time (days) until appearance of first wheezing attack (WA) |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Health and Social Resources During the Whole Period of the Study. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Casanovas, PhD; MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Manises | Manises | Valencia | 46940 | Spain | ||
| Hospital Universitario y Politécnico La Fe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21391984 | Background | 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. | |
| 33705665 |
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October 2012 - May 2015 subjects enrollment. 120 children <3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year. . WA were confirmed by the review of the medical records. Aeroallergen sensitization at baseline was used as an exclusion criterion to avoid an eventual WA due to allergic asthma.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation Biological vaccine: daily spray (2 puff of 100 µL) for six months |
| FG001 | 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 Biological vaccine: daily spray (2 puff of 100 µL) for six months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
<3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation Biological vaccine: daily spray (2 puff of 100 µL) for six months |
| BG001 | Biological Vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | events | 12 months |
|
Up to 12 months.
Adverse Events were registered throughout the trial. Grading was according to EAACI guidelines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation Biological vaccine: daily spray (2 puff of 100 µL) for six months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilectic seizure | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Inmunotek | 916 510 010 | mcasanovas@inmunotek.com |
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| ID | Term |
|---|---|
| D001986 | Bronchial Spasm |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
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| 12 months |
| Number of Days With Wheezing Attacks During the Study | Review of the number of days with wheezing attacks during the study | 12 months |
| Number of Patients With Recurrent WA During the Study | Review of number of patients with recurrent WA during the whole study | 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. | 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. | 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 | 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. | 12 months |
| 12 months |
| Valencia |
| 46026 |
| Spain |
| Derived |
| 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. |
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 vaccine: daily spray (2 puff of 100 µL) for six months
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Duration (Days) of Wheezing Attacks (WA) | Review of bronchospasm (wheezing attacks) duration per patient | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| Secondary | Time Until Appearance of First WA | time (days) until appearance of first wheezing attack (WA) | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| Secondary | Number of Days With Wheezing Attacks During the Study | Review of the number of days with wheezing attacks during the study | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| Secondary | Number of Patients With Recurrent WA During the Study | Review of number of patients with recurrent WA during the whole study | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 months |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 months |
|
|
|
| Other Pre-specified | Use of Health and Social Resources During the Whole Period of the Study. | 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) | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| 0 |
| 58 |
| 1 |
| 58 |
| 0 |
| 58 |
| EG001 | 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 Biological vaccine: daily spray (2 puff of 100 µL) for six months | 0 | 62 | 0 | 62 | 0 | 62 |
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| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |