Asthma, Children
Conditions
Keywords
asthma, albuterol, metered dose inhalers
Brief summary
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.
Detailed description
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.
Interventions
DRUGAlbuterol - Experimental
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).
DRUGAlbuterol - Control
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)
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 2 to 18 years; 2. History of two or more previous episodes of wheezing treated with bronchodilators in the last year; 3. Wheezing attacks characterized by coughing, difficulty breathing and auscultation of expiratory wheezing or prolonged expiration; 4. Intensity of wheezing attacks defined by PRAM score as moderate or severe (PRAM ≥ 5).
Exclusion criteria
1. Pre-existing chronic diseases such as bronchopulmonary dysplasia, cystic fibrosis, bronchiolitis obliterans or other chronic pulmonary or cardiovascular disease; 2. Initial clinical status indicating immediate ventilatory support, need for subcutaneous or intravenous bronchodilators; 3. Decreased level of consciousness; 4. Using a β-agonist in the four hours prior to arrival. 5. Use of corticosteroids in the last 24h.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Admission | Starting at 4 hours post-treatment | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in the First Second | One hour post-treatment in comparison with baseline | 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. |
| Change in PRAM Score After One Hour | One hour post-treatment | 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 |
| Albuterol Determination in the Plasma | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) | 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. |
| Changes in Glucose Serum Levels | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. | Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
| Electrocardiogram at Baseline | at baseline | Electrocardiogram performed at baseline |
| Changes in Respiratory Rate After One Hour | One hour post-treatment in comparison with baseline | Change in respiratory rate one hour post-treatment in comparison with baseline. |
| Need for Additional Therapies | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) | The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded |
| Changes in PRAM Score at Discharge or Hospital Admission | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. | 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 |
| Changes in Potassium Serum Levels | 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 at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
| Changes in Bicarbonate Serum Levels | 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 at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
| Change in Pulse Oximetry One Hour Post-treatment | One hour post-treatment in comparison with baseline | Change in pulse oximetry one hour post-treatment in comparison with baseline |
| Changes in Pulse Oximetry at Discharge or Hospital Admission. | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline. | Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
| Changes in Heart Rate After One Hour | One hour post-treatment in comparison with baseline | Change in heart rate one hour post-treatment in comparison with baseline. |
| Changes in Heart Rate at Discharge or Hospital Admission | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) | Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
| Electrocardiogram One Hour Post-treatment. | One hour post-treatment | Electrocardiogram one hour post-treatment to identify possible rhythm disturbances. |
| Electrocardiogram at Discharge or Hospital Admission | at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) | Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances. |
| Lengths of Stay in the Emergency Room | one to four hours | lengths of stay in the emergency room for discharged patients |
| Admission Rates in Patients With and Without Any Virus Detected | 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 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. |
| Admission Rates in Patients With and Without Rhinovirus Detect | 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 detected by PCR in nasal lavage samples. |
| Admission Rates in Patients With the Arg16Gly Polymorphisms | 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 of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes). |
| Changes in Respiratory Rate at at Discharge or Hospital Admission. | 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 discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 59 |
| Total | 119 |
Baseline characteristics
| Characteristic | Control Group | Total | Experimental Group |
|---|---|---|---|
| Age, Continuous | 6.42 years STANDARD_DEVIATION 3.74 | 6.55 years STANDARD_DEVIATION 3.52 | 6.68 years STANDARD_DEVIATION 3.38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 34 Participants | 66 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 17 Participants | 9 Participants |
| Race (NIH/OMB) White | 12 Participants | 28 Participants | 16 Participants |
| Sex: Female, Male Female | 26 Participants | 56 Participants | 30 Participants |
| Sex: Female, Male Male | 33 Participants | 63 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 60 | 37 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
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%)
Time frame: Starting at 4 hours post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Hospital Admission | 11 participants |
| Albuterol - Lower Dose (Control) | Hospital Admission | 8 participants |
p-value: 0.689Chi-squared
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Admission Rates in Patients With and Without Any Virus Detected | 12.3 percentage of participants |
| Albuterol - Lower Dose (Control) | Admission Rates in Patients With and Without Any Virus Detected | 22.7 percentage of participants |
p-value: 0.195Chi-squared
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Admission Rates in Patients With and Without Rhinovirus Detect | 10.2 percentage of participants |
| Albuterol - Lower Dose (Control) | Admission Rates in Patients With and Without Rhinovirus Detect | 20.6 percentage of participants |
p-value: 0.203Chi-squared, Corrected
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).
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Admission Rates in Patients With the Arg16Gly Polymorphisms | 1 participants |
| Albuterol - Lower Dose (Control) | Admission Rates in Patients With the Arg16Gly Polymorphisms | 1 participants |
| Arg16Arg Patients | Admission Rates in Patients With the Arg16Gly Polymorphisms | 7 participants |
p-value: 0.03Chi-squared
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Albuterol Determination in the Plasma | 2.57 ng/ml |
| Albuterol - Lower Dose (Control) | Albuterol Determination in the Plasma | 1.08 ng/ml |
p-value: 0.042Wilcoxon (Mann-Whitney)
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
Time frame: One hour post-treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Change in PRAM Score After One Hour | -3 units on a scale |
| Albuterol - Lower Dose (Control) | Change in PRAM Score After One Hour | -4 units on a scale |
p-value: 0.15ANOVA
Secondary
Change in Pulse Oximetry One Hour Post-treatment
Change in pulse oximetry one hour post-treatment in comparison with baseline
Time frame: One hour post-treatment in comparison with baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Change in Pulse Oximetry One Hour Post-treatment | 1.54 percentage of oxygen saturation | Standard Error 0.29 |
| Albuterol - Lower Dose (Control) | Change in Pulse Oximetry One Hour Post-treatment | 1.39 percentage of oxygen saturation | Standard Error 0.3 |
p-value: 0.723ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Bicarbonate Serum Levels | -1.75 mmol/L | Standard Error 0.26 |
| Albuterol - Lower Dose (Control) | Changes in Bicarbonate Serum Levels | -1.44 mmol/L | Standard Error 0.29 |
p-value: 0.436ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Glucose Serum Levels | 34.73 mg/dL | Standard Error 5.05 |
| Albuterol - Lower Dose (Control) | Changes in Glucose Serum Levels | 22.90 mg/dL | Standard Error 5.25 |
p-value: 0.108ANOVA
Secondary
Changes in Heart Rate After One Hour
Change in heart rate one hour post-treatment in comparison with baseline.
Time frame: One hour post-treatment in comparison with baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Heart Rate After One Hour | 1.75 beats per minute | Standard Error 2.12 |
| Albuterol - Lower Dose (Control) | Changes in Heart Rate After One Hour | -1.47 beats per minute | Standard Error 2.12 |
p-value: 0.284ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Heart Rate at Discharge or Hospital Admission | -0.263 beats per minute | Standard Error 2.17 |
| Albuterol - Lower Dose (Control) | Changes in Heart Rate at Discharge or Hospital Admission | -0.65 beats per minute | Standard Error 2.17 |
p-value: 0.905ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Potassium Serum Levels | -0.38 mEq/L | Standard Error 0.1 |
| Albuterol - Lower Dose (Control) | Changes in Potassium Serum Levels | -0.59 mEq/L | Standard Error 0.1 |
p-value: 0.165ANOVA
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
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in PRAM Score at Discharge or Hospital Admission | -4.5 units on a scale |
| Albuterol - Lower Dose (Control) | Changes in PRAM Score at Discharge or Hospital Admission | -5 units on a scale |
p-value: 0.164ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Pulse Oximetry at Discharge or Hospital Admission. | 2.14 percentage of oxygen saturation | Standard Deviation 0.32 |
| Albuterol - Lower Dose (Control) | Changes in Pulse Oximetry at Discharge or Hospital Admission. | 1.59 percentage of oxygen saturation | Standard Deviation 0.33 |
p-value: 0.235ANOVA
Secondary
Changes in Respiratory Rate After One Hour
Change in respiratory rate one hour post-treatment in comparison with baseline.
Time frame: One hour post-treatment in comparison with baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Respiratory Rate After One Hour | -2.08 breaths per minute | Standard Error 1.03 |
| Albuterol - Lower Dose (Control) | Changes in Respiratory Rate After One Hour | -4.31 breaths per minute | Standard Error 0.99 |
p-value: 0.122ANOVA
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.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Changes in Respiratory Rate at at Discharge or Hospital Admission. | -2.92 breaths per minute | Standard Error 1.03 |
| Albuterol - Lower Dose (Control) | Changes in Respiratory Rate at at Discharge or Hospital Admission. | -5.76 breaths per minute | Standard Error 0.99 |
p-value: 0.046ANOVA
Secondary
Electrocardiogram at Baseline
Electrocardiogram performed at baseline
Time frame: at baseline
Population: no electrocardiopraphic abnormalities were detected in both groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Electrocardiogram at Baseline | 0 participants with ECG abnormalities |
| Albuterol - Lower Dose (Control) | Electrocardiogram at Baseline | 0 participants with ECG abnormalities |
Secondary
Electrocardiogram at Discharge or Hospital Admission
Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: No electrocardiographic abnormalities were detected in both groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Electrocardiogram at Discharge or Hospital Admission | 0 participants with ECG abnormalities |
| Albuterol - Lower Dose (Control) | Electrocardiogram at Discharge or Hospital Admission | 0 participants with ECG abnormalities |
Secondary
Electrocardiogram One Hour Post-treatment.
Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.
Time frame: One hour post-treatment
Population: No electrocardiographic abnormalities were detected im both groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Electrocardiogram One Hour Post-treatment. | 0 participants with ECG abnormalities |
| Albuterol - Lower Dose (Control) | Electrocardiogram One Hour Post-treatment. | 0 participants with ECG abnormalities |
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.
Time frame: One hour post-treatment in comparison with baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol - Higher Dose (Experimental) | Forced Expiratory Volume in the First Second | 14.67 percentage of predicted | Standard Deviation 16.62 |
| Albuterol - Lower Dose (Control) | Forced Expiratory Volume in the First Second | 11.3 percentage of predicted | Standard Deviation 15.62 |
p-value: 0.591t-test, 2 sided
Secondary
Lengths of Stay in the Emergency Room
lengths of stay in the emergency room for discharged patients
Time frame: one to four hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Lengths of Stay in the Emergency Room | 1.50 hours |
| Albuterol - Lower Dose (Control) | Lengths of Stay in the Emergency Room | 1.40 hours |
p-value: 0.892Wilcoxon (Mann-Whitney)
Secondary
Need for Additional Therapies
The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded
Time frame: at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)
Population: no patients received magnesium sulphate or intravenous albuterol in both groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol - Higher Dose (Experimental) | Need for Additional Therapies | 0 participants |
| Albuterol - Lower Dose (Control) | Need for Additional Therapies | 0 participants |