A Phase 3 interventional study of Biological vaccine in Bronchospasm; Bronchiolitis and Bronchospasm; Bronchitis, sponsored by Inmunotek S.L.. Completed at 2 sites in Spain. Open to participants aged 12 Months to 36 Months. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Prevention
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.
44 studies on the registry are indexed under Bronchial Spasm; 4 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 29 interventional studies indexed under Bronchial Spasm.
Browse Bronchial Spasm studies →Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation
Biological: 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: Biological vaccine
daily spray (2 puff of 100 µL) for six months
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
Time frame: 12 months
Duration (Days) of Wheezing Attacks (WA)
Review of bronchospasm (wheezing attacks) duration per patient
Time frame: 12 months
Time Until Appearance of First WA
time (days) until appearance of first wheezing attack (WA)
Time frame: 12 months
Number of Days With Wheezing Attacks During the Study
Review of the number of days with wheezing attacks during the study
Time frame: 12 months
Number of Patients With Recurrent WA During the Study
Review of number of patients with recurrent WA during the whole study
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 12 months
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)
Time frame: 12 months
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.
| Milestone | Placebo | Biological Vaccine |
|---|---|---|
| Started | 58 | 62 |
| Completed | 54 | 59 |
| Not completed | 4 | 3 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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
| events | Placebo | Biological Vaccine |
|---|---|---|
| Number of Recurrent Bronchospasm (Wheezing Attacks) | 299 | 176 |
Review of bronchospasm (wheezing attacks) duration per patient
| days | Placebo | Biological Vaccine |
|---|---|---|
| Duration (Days) of Wheezing Attacks (WA) | 7.9 (6.2 to 11.0) | 6.0 (4.0 to 9.5) |
time (days) until appearance of first wheezing attack (WA)
| days | Placebo | Biological Vaccine |
|---|---|---|
| Time Until Appearance of First WA | 5.0 (2.0 to 28.8) | 41.0 (15.0 to 94.5) |
Review of the number of days with wheezing attacks during the study
| days | Placebo | Biological Vaccine |
|---|---|---|
| Number of Days With Wheezing Attacks During the Study | 42.0 (17.0 to 57.5) | 19.2 (8.5 to 35.0) |
Review of number of patients with recurrent WA during the whole study
| Participants | Placebo | Biological Vaccine |
|---|---|---|
| Number of Patients With Recurrent WA During the Study | 45 | 36 |
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.
| units on a scale | Placebo | Biological Vaccine |
|---|---|---|
| Symptom Score During Wheezing Attacks | 155.0 (79.0 to 244.5) | 80.0 (19.5 to 154.5) |
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.
| units on a scale | Placebo | Biological Vaccine |
|---|---|---|
| Medication Score During WA | 424.0 (185.0 to 738.5) | 164.0 (43.5 to 311.5) |
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
| units on a scale | Placebo | Biological Vaccine |
|---|---|---|
| Overall Symptom Score | 421.0 (303.0 to 673.0) | 276.5 (151.0 to 426.0) |
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.
| units on a scale | Placebo | Biological Vaccine |
|---|---|---|
| Overall Medication Score | 1043.5 (669.5 to 1696.0) | 618.5 (318.3 to 1035.5) |
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)
| days | Placebo | Biological Vaccine |
|---|---|---|
| Use of Health and Social Resources During the Whole Period of the Study. | 14.5 (2 to 52) | 11.0 (0 to 44) |
Collected over Up to 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/58 (0%) | 1/58 (1.7%) | 0/58 (0%) |
| Biological Vaccine | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Event | Placebo | Biological Vaccine |
|---|---|---|
| Epilectic seizureNervous system disorders | 1/58 | — |
\<3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year.
| Age, Categorical(Participants) | Placebo | Biological Vaccine | Total |
|---|---|---|---|
| <=18 years | 58 | 62 | 120 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | Placebo | Biological Vaccine | Total |
|---|---|---|---|
| Mean | 23 ± 8 | 23 ± 7 | 23 ± 8 |
| Sex: Female, Male(Participants) | Placebo | Biological Vaccine | Total |
|---|---|---|---|
| Female | 26 | 25 | 51 |
| Male | 32 | 37 | 69 |
| Region of Enrollment(participants) | Placebo | Biological Vaccine | Total |
|---|---|---|---|
| Spain | 58 | 62 | 120 |
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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