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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
This is a prospective, randomized, double blinded, controlled study. The patients will be randomly assigned to one of the treatment groups (experimental or control groups).
The patients will be assessed 1 hour later and every 30 minutes thereafter until discharge. Following 4 hours in the emergency room, any patient who do not meet the discharge criteria (PRAM score ≤ 3 and SpO2 ≥ 92%) will be admitted to the hospital. Each patient's attending physician will determine the need for additional therapies following the first hour.
Identification of respiratory viruses in the nasal lavage samples wil be performed using the CLART PneumoVir® kit.
Albuterol plasmatic levels will be analyzed via HPLC (High Performance Liquid Chromatography).
To genotype the ADBR2 receptor (blood samples), the gene regions encompassing the Arg16Gly, Gln27Glu, and Arg19Cys Thr164Ile polymorphisms will be amplified via PCR. The resultant amplimers were then sequenced.
A sample of 124 patients (62 in each group) was calculated to provide an 80% power with which to detect a significant difference of at least 30 minutes in the lengths of stay between the groups. The chi-square test will be used to compare hospital admission rates and tremor rates. For all other outcomes, t-tests for mean comparisons (variables with a normal distribution), a Mann Whitney test (nonparametric data) and ANOVA with repeated measures will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol - Experimental | Experimental | Albuterol dosages during the first hour include 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg). |
|
| Albuterol - Control | Active Comparator | Albuterol dosages during the first hour include either 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol - Experimental | Drug | The Experimental group will receive higher doses of albuterol in the first hour: 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Admission | Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%) | Starting at 4 hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in the First Second | Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly. | One hour post-treatment in comparison with baseline |
| Change in PRAM Score After One Hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luiz Vicente RF Silva Filho, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto da Crianca HCFMUSP | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35352766 | Derived | Muchao FP, Souza AV, Souza JME, Silva Filho LVRFD. Association between beta-2 adrenergic receptor variants and clinical outcomes in children and adolescents with acute asthma. Einstein (Sao Paulo). 2022 Mar 25;20:eAO6412. doi: 10.31744/einstein_journal/2022AO6412. eCollection 2022. | |
| 27171324 | Derived | Muchao FP, Souza JM, Torres HC, De Lalibera IB, de Souza AV, Rodrigues JC, Schvartsman C, da Silva Filho LV. Albuterol via metered-dose inhaler in children: Lower doses are effective, and higher doses are safe. Pediatr Pulmonol. 2016 Nov;51(11):1122-1130. doi: 10.1002/ppul.23469. Epub 2016 May 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Albuterol - Higher Dose (Experimental) | Dosing will be individualized in four categories according to body weight Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg |
| FG001 | Albuterol - Lower Dose (Control) | Dosing will be dived according to consensus recommendations in only two categories according to body weight Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | Dosing will be individualized in four categories according to body weight Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hospital Admission | Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%) | Posted | Number | participants | Starting at 4 hours post-treatment |
|
At discharge or hospital admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post-baseline).
At discharge or hospital admission (up to 4 hours post-baseline, minimum 1 hour, maximum 4 hours) all possible adverse effects were monitored: significant changes in potassium and glucose and bicarbonate serum levels, electrocardiographic abnormalities or any clinical adverse effect.
The last adverse event was detected 4 hours post-treatment.
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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 | Experimental Group | Dosing was individualized in four categories according to body weight Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non symptomatic mild hypokalemia at discharge or hospital admission (up to 4 hours post-baseline). | Blood and lymphatic system disorders | Systematic Assessment |
The inclusion of a larger number of patients in this study may have uncovered differences in the efficacy outcomes studied between the groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Fabio Pereira Muchão | University of Sao Paulo | +5511 983835563 | fabiomuchao@gmail.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Albuterol - Control | Drug | The Control group will receive the following doses of albuterol in the first hour 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg) |
|
|
Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline. The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack. We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline). The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2). minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0 minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0 |
| One hour post-treatment |
| Albuterol Determination in the Plasma | Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Changes in Glucose Serum Levels | Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Electrocardiogram at Baseline | Electrocardiogram performed at baseline | at baseline |
| Changes in Respiratory Rate After One Hour | Change in respiratory rate one hour post-treatment in comparison with baseline. | One hour post-treatment in comparison with baseline |
| Need for Additional Therapies | The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Changes in PRAM Score at Discharge or Hospital Admission | Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack. We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline). The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2). minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0 minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1 | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Changes in Potassium Serum Levels | Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Changes in Bicarbonate Serum Levels | Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Changes in Respiratory Rate at at Discharge or Hospital Admission. | Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Change in Pulse Oximetry One Hour Post-treatment | Change in pulse oximetry one hour post-treatment in comparison with baseline | One hour post-treatment in comparison with baseline |
| Changes in Pulse Oximetry at Discharge or Hospital Admission. | Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
| Changes in Heart Rate After One Hour | Change in heart rate one hour post-treatment in comparison with baseline. | One hour post-treatment in comparison with baseline |
| Changes in Heart Rate at Discharge or Hospital Admission | Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Electrocardiogram One Hour Post-treatment. | Electrocardiogram one hour post-treatment to identify possible rhythm disturbances. | One hour post-treatment |
| Electrocardiogram at Discharge or Hospital Admission | Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Lengths of Stay in the Emergency Room | lengths of stay in the emergency room for discharged patients | one to four hours |
| Admission Rates in Patients With and Without Any Virus Detected | Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Admission Rates in Patients With and Without Rhinovirus Detect | Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Admission Rates in Patients With the Arg16Gly Polymorphisms | Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes). | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
| Control Group |
Dosing will be dived according to consensus recommendations in only two categories according to body weight Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Forced Expiratory Volume in the First Second | Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly. | Posted | Mean | Standard Deviation | percentage of predicted | One hour post-treatment in comparison with baseline |
|
|
|
|
| Secondary | Change in PRAM Score After One Hour | Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline. The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack. We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline). The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2). minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0 minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0 | Posted | Mean | Inter-Quartile Range | units on a scale | One hour post-treatment |
|
|
|
|
| Secondary | Albuterol Determination in the Plasma | Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography. | It was possible to obtain albuterol plasma levels from 52 patients in the study group and 51 in the control group (in the other samples, this analysis was not feasible due to hemolysis). | Posted | Median | Inter-Quartile Range | ng/ml | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
|
|
|
|
| Secondary | Changes in Glucose Serum Levels | Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | It was possible to obtain glucose serum levels from 57 patients in the study group and 55 in the control group (in the other samples, this analysis was not feasible due to hemolysis). | Posted | Mean | Standard Error | mg/dL | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
|
|
|
|
| Secondary | Electrocardiogram at Baseline | Electrocardiogram performed at baseline | no electrocardiopraphic abnormalities were detected in both groups | Posted | Number | participants with ECG abnormalities | at baseline |
|
|
|
| Secondary | Changes in Respiratory Rate After One Hour | Change in respiratory rate one hour post-treatment in comparison with baseline. | Posted | Mean | Standard Error | breaths per minute | One hour post-treatment in comparison with baseline |
|
|
|
|
| Secondary | Need for Additional Therapies | The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded | no patients received magnesium sulphate or intravenous albuterol in both groups | Posted | Number | participants | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
|
|
|
| Secondary | Changes in PRAM Score at Discharge or Hospital Admission | Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack. We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline). The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2). minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0 minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1 | Posted | Median | Inter-Quartile Range | units on a scale | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
|
|
|
|
| Secondary | Changes in Potassium Serum Levels | Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | It was possible to obtain potassium serum levels from 54 patients in the study group and 56 in the control group (in the other samples, this analysis was not feasible due to hemolysis). | Posted | Mean | Standard Error | mEq/L | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
|
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|
| Secondary | Changes in Bicarbonate Serum Levels | Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | It was possible to obtain bicarbonate serum levels from 42 patients in the study group and 37 in the control group (in the other samples, this analysis was not feasible due to the long time to transport the samples to the laboratory in one of our centers). | Posted | Mean | Standard Error | mmol/L | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
|
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|
| Secondary | Changes in Respiratory Rate at at Discharge or Hospital Admission. | Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | Posted | Mean | Standard Error | breaths per minute | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
|
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| Secondary | Change in Pulse Oximetry One Hour Post-treatment | Change in pulse oximetry one hour post-treatment in comparison with baseline | Posted | Mean | Standard Error | percentage of oxygen saturation | One hour post-treatment in comparison with baseline |
|
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|
| Secondary | Changes in Pulse Oximetry at Discharge or Hospital Admission. | Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. |
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| Secondary | Changes in Heart Rate After One Hour | Change in heart rate one hour post-treatment in comparison with baseline. | Posted | Mean | Standard Error | beats per minute | One hour post-treatment in comparison with baseline |
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|
| Secondary | Changes in Heart Rate at Discharge or Hospital Admission | Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. | Posted | Mean | Standard Error | beats per minute | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
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| Secondary | Electrocardiogram One Hour Post-treatment. | Electrocardiogram one hour post-treatment to identify possible rhythm disturbances. | No electrocardiographic abnormalities were detected im both groups | Posted | Number | participants with ECG abnormalities | One hour post-treatment |
|
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| Secondary | Electrocardiogram at Discharge or Hospital Admission | Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances. | No electrocardiographic abnormalities were detected in both groups. | Posted | Number | participants with ECG abnormalities | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
|
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| Secondary | Lengths of Stay in the Emergency Room | lengths of stay in the emergency room for discharged patients | Posted | Median | Inter-Quartile Range | hours | one to four hours |
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| Secondary | Admission Rates in Patients With and Without Any Virus Detected | Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B. | We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples. | Posted | Number | percentage of participants | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
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| Secondary | Admission Rates in Patients With and Without Rhinovirus Detect | Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples. | We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples. | Posted | Number | percentage of participants | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
|
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|
|
| Secondary | Admission Rates in Patients With the Arg16Gly Polymorphisms | Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes). | The sequencing of the beta-2 adrenergic receptor gene was performed in a subset of 60 patients, in the other samples these analysis were not feasible due to hemolysis. | Posted | Number | participants | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) |
|
|
|
|
| 0 |
| 60 |
| 36 |
| 60 |
| EG001 | Control Group | Dosing was dived according to consensus recommendations in only two categories according to body weight Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg | 0 | 59 | 37 | 59 |
Non symptomatic mild hypokalemia in 17 patients, 10 in the control group, 7 in the experimental group.
Only 2 patients showed values below 3.1 mEq/L. One patient in the experimental group: 2.8 mEq/L. One patient in the control group: 2.9mEq/L
|
| non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post-baseline) | Blood and lymphatic system disorders | Systematic Assessment | Non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment). No patients needed medical intervention. |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |