Trial Outcomes & Findings for Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes (NCT NCT01323010)

NCT ID: NCT01323010

Last Updated: 2016-03-14

Results Overview

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%)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 119 participants
• Primary outcome timeframe: Starting at 4 hours post-treatment
• Results posted on: 2016-03-14

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	60	59
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes

Baseline characteristics by cohort

Measure	Experimental Group n=60 Participants 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	Control Group n=59 Participants 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	Total n=119 Participants Total of all reporting groups
Age, Continuous	6.68 years STANDARD_DEVIATION 3.38 • n=5 Participants	6.42 years STANDARD_DEVIATION 3.74 • n=7 Participants	6.55 years STANDARD_DEVIATION 3.52 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	26 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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%)

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Hospital Admission	11 participants	8 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=18 Participants 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	Albuterol - Lower Dose (Control) n=12 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Forced Expiratory Volume in the First Second	14.67 percentage of predicted Standard Deviation 16.62	11.3 percentage of predicted Standard Deviation 15.62	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Change in PRAM Score After One Hour	-3 units on a scale Interval -5.0 to -2.0	-4 units on a scale Interval -5.0 to -3.0	—

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=52 Participants 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	Albuterol - Lower Dose (Control) n=51 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Albuterol Determination in the Plasma	2.57 ng/ml Interval 0.0 to 15.8	1.08 ng/ml Interval 0.0 to 14.5	—

SECONDARY outcome

Timeframe: 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).

Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=57 Participants 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	Albuterol - Lower Dose (Control) n=55 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Glucose Serum Levels	34.73 mg/dL Standard Error 5.05	22.90 mg/dL Standard Error 5.25	—

SECONDARY outcome

Timeframe: at baseline

Population: no electrocardiopraphic abnormalities were detected in both groups

Electrocardiogram performed at baseline

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Electrocardiogram at Baseline	0 participants with ECG abnormalities	0 participants with ECG abnormalities	—

SECONDARY outcome

Timeframe: One hour post-treatment in comparison with baseline

Change in respiratory rate one hour post-treatment in comparison with baseline.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Respiratory Rate After One Hour	-2.08 breaths per minute Standard Error 1.03	-4.31 breaths per minute Standard Error 0.99	—

SECONDARY outcome

Timeframe: 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

The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Need for Additional Therapies	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in PRAM Score at Discharge or Hospital Admission	-4.5 units on a scale Interval -6.0 to -3.0	-5 units on a scale Interval -6.0 to -4.0	—

SECONDARY outcome

Timeframe: 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).

Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=54 Participants 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	Albuterol - Lower Dose (Control) n=56 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Potassium Serum Levels	-0.38 mEq/L Standard Error 0.10	-0.59 mEq/L Standard Error 0.10	—

SECONDARY outcome

Timeframe: 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).

Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=42 Participants 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	Albuterol - Lower Dose (Control) n=37 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Bicarbonate Serum Levels	-1.75 mmol/L Standard Error 0.26	-1.44 mmol/L Standard Error 0.29	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Respiratory Rate at at Discharge or Hospital Admission.	-2.92 breaths per minute Standard Error 1.03	-5.76 breaths per minute Standard Error 0.99	—

SECONDARY outcome

Timeframe: One hour post-treatment in comparison with baseline

Change in pulse oximetry one hour post-treatment in comparison with baseline

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Change in Pulse Oximetry One Hour Post-treatment	1.54 percentage of oxygen saturation Standard Error 0.29	1.39 percentage of oxygen saturation Standard Error 0.30	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Pulse Oximetry at Discharge or Hospital Admission.	2.14 percentage of oxygen saturation Standard Deviation 0.32	1.59 percentage of oxygen saturation Standard Deviation 0.33	—

SECONDARY outcome

Timeframe: One hour post-treatment in comparison with baseline

Change in heart rate one hour post-treatment in comparison with baseline.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Heart Rate After One Hour	1.75 beats per minute Standard Error 2.12	-1.47 beats per minute Standard Error 2.12	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Changes in Heart Rate at Discharge or Hospital Admission	-0.263 beats per minute Standard Error 2.17	-0.65 beats per minute Standard Error 2.17	—

SECONDARY outcome

Timeframe: One hour post-treatment

Population: No electrocardiographic abnormalities were detected im both groups

Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Electrocardiogram One Hour Post-treatment.	0 participants with ECG abnormalities	0 participants with ECG abnormalities	—

SECONDARY outcome

Timeframe: 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.

Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Electrocardiogram at Discharge or Hospital Admission	0 participants with ECG abnormalities	0 participants with ECG abnormalities	—

SECONDARY outcome

Timeframe: one to four hours

lengths of stay in the emergency room for discharged patients

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=60 Participants 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	Albuterol - Lower Dose (Control) n=59 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Lengths of Stay in the Emergency Room	1.50 hours Interval 1.0 to 2.0	1.40 hours Interval 1.0 to 1.5	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=73 Participants 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	Albuterol - Lower Dose (Control) n=44 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Admission Rates in Patients With and Without Any Virus Detected	12.3 percentage of participants	22.7 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=49 Participants 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	Albuterol - Lower Dose (Control) n=68 Participants 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	Arg16Arg Patients Patients carrying the Arg16Arg genotype
Admission Rates in Patients With and Without Rhinovirus Detect	10.2 percentage of participants	20.6 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).

Outcome measures

Measure	Albuterol - Higher Dose (Experimental) n=16 Participants 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	Albuterol - Lower Dose (Control) n=21 Participants 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	Arg16Arg Patients n=23 Participants Patients carrying the Arg16Arg genotype
Admission Rates in Patients With the Arg16Gly Polymorphisms	1 participants	1 participants	7 participants

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental Group n=60 participants at risk 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	Control Group n=59 participants at risk 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
Blood and lymphatic system disorders non symptomatic mild hypokalemia at discharge or hospital admission (up to 4 hours post-baseline).	11.7% 7/60 • Number of events 7 • 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.	16.9% 10/59 • Number of events 10 • 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.
Blood and lymphatic system disorders non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post-baseline)	48.3% 29/60 • Number of events 29 • 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.	45.8% 27/59 • Number of events 27 • 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.

Additional Information

Dr Fabio Pereira Muchão

University of Sao Paulo

Phone: +5511 983835563

Email: fabiomuchao@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place