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

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ClinicalTrials.gov Identifier: NCT01323010
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Asthma
Children
Interventions Drug: Albuterol - Experimental
Drug: Albuterol - Control
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 60 59
Completed 60 59
Not Completed 0 0
Arm/Group Title Experimental Group Control Group Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 60 59 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 59 participants 119 participants
6.68  (3.38) 6.42  (3.74) 6.55  (3.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 119 participants
Female
30
  50.0%
26
  44.1%
56
  47.1%
Male
30
  50.0%
33
  55.9%
63
  52.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 119 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   5.0%
5
   8.5%
8
   6.7%
White
16
  26.7%
12
  20.3%
28
  23.5%
More than one race
32
  53.3%
34
  57.6%
66
  55.5%
Unknown or Not Reported
9
  15.0%
8
  13.6%
17
  14.3%
1.Primary Outcome
Title Hospital Admission
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: participants
11 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Forced Expiratory Volume in the First Second
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

Dosing was individualized 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

Overall Number of Participants Analyzed 18 12
Mean (Standard Deviation)
Unit of Measure: percentage of predicted
14.67  (16.62) 11.3  (15.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.591
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in PRAM Score After One Hour
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 60 59
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
-3
(-5 to -2)
-4
(-5 to -3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANOVA
Comments Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.
4.Secondary Outcome
Title Albuterol Determination in the Plasma
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 52 51
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
2.57
(0 to 15.8)
1.08
(0 to 14.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Glucose Serum Levels
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 57 55
Mean (Standard Error)
Unit of Measure: mg/dL
34.73  (5.05) 22.90  (5.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Electrocardiogram at Baseline
Hide Description Electrocardiogram performed at baseline
Time Frame at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
no electrocardiopraphic abnormalities were detected in both groups
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: participants with ECG abnormalities
0 0
7.Secondary Outcome
Title Changes in Respiratory Rate After One Hour
Hide Description Change in respiratory rate one hour post-treatment in comparison with baseline.
Time Frame One hour post-treatment in comparison with baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Error)
Unit of Measure: breaths per minute
-2.08  (1.03) -4.31  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Need for Additional Therapies
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
no patients received magnesium sulphate or intravenous albuterol in both groups
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Changes in PRAM Score at Discharge or Hospital Admission
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-4.5
(-6 to -3)
-5
(-6 to -4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANOVA
Comments Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.
10.Secondary Outcome
Title Changes in Potassium Serum Levels
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 54 56
Mean (Standard Error)
Unit of Measure: mEq/L
-0.38  (0.10) -0.59  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Changes in Bicarbonate Serum Levels
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 42 37
Mean (Standard Error)
Unit of Measure: mmol/L
-1.75  (0.26) -1.44  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.436
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Changes in Respiratory Rate at at Discharge or Hospital Admission.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Error)
Unit of Measure: breaths per minute
-2.92  (1.03) -5.76  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change in Pulse Oximetry One Hour Post-treatment
Hide Description Change in pulse oximetry one hour post-treatment in comparison with baseline
Time Frame One hour post-treatment in comparison with baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Error)
Unit of Measure: percentage of oxygen saturation
1.54  (0.29) 1.39  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
14.Secondary Outcome
Title Changes in Pulse Oximetry at Discharge or Hospital Admission.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
2.14  (0.32) 1.59  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
15.Secondary Outcome
Title Changes in Heart Rate After One Hour
Hide Description Change in heart rate one hour post-treatment in comparison with baseline.
Time Frame One hour post-treatment in comparison with baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Error)
Unit of Measure: beats per minute
1.75  (2.12) -1.47  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
16.Secondary Outcome
Title Changes in Heart Rate at Discharge or Hospital Admission
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Mean (Standard Error)
Unit of Measure: beats per minute
-0.263  (2.17) -0.65  (2.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
17.Secondary Outcome
Title Electrocardiogram One Hour Post-treatment.
Hide Description Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.
Time Frame One hour post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No electrocardiographic abnormalities were detected im both groups
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: participants with ECG abnormalities
0 0
18.Secondary Outcome
Title Electrocardiogram at Discharge or Hospital Admission
Hide Description 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)
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Hide Analysis Population Description
No electrocardiographic abnormalities were detected in both groups.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Measure Type: Number
Unit of Measure: participants with ECG abnormalities
0 0
19.Secondary Outcome
Title Lengths of Stay in the Emergency Room
Hide Description lengths of stay in the emergency room for discharged patients
Time Frame one to four hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol - Higher Dose (Experimental) Albuterol - Lower Dose (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 60 59
Median (Inter-Quartile Range)
Unit of Measure: hours
1.50
(1 to 2)
1.40
(1 to 1.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol - Higher Dose (Experimental), Albuterol - Lower Dose (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.892
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Admission Rates in Patients With and Without Any Virus Detected
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.
Arm/Group Title Virus Detected No Virus Detected
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patients with any virus detected by PCR
patients with no virus detected by PCR
Overall Number of Participants Analyzed 73 44
Measure Type: Number
Unit of Measure: percentage of participants
12.3 22.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Virus Detected, No Virus Detected
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
21.Secondary Outcome
Title Admission Rates in Patients With and Without Rhinovirus Detect
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.
Arm/Group Title Rhinovirus Detected No Rhinovirus Detected
Hide Arm/Group Description:
patients with rhinovirus detected by PCR
patients with no rhinovirus detected by PCR
Overall Number of Participants Analyzed 49 68
Measure Type: Number
Unit of Measure: percentage of participants
10.2 20.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rhinovirus Detected, No Rhinovirus Detected
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
22.Secondary Outcome
Title Admission Rates in Patients With the Arg16Gly Polymorphisms
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Arg16Gly Patients Gly16Gly Patients Arg16Arg Patients
Hide Arm/Group Description:
Patients carrying the Arg16Gly genotype
Patients carrying the Gly16Gly genotype
Patients carrying the Arg16Arg genotype
Overall Number of Participants Analyzed 16 21 23
Measure Type: Number
Unit of Measure: participants
1 1 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arg16Gly Patients, Gly16Gly Patients, Arg16Arg Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame At discharge or hospital admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post-baseline).
Adverse Event Reporting Description

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.

 
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description

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

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

All-Cause Mortality
Experimental Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/60 (60.00%)      37/59 (62.71%)    
Blood and lymphatic system disorders     
non symptomatic mild hypokalemia at discharge or hospital admission (up to 4 hours post-baseline).  [1]  7/60 (11.67%)  7 10/59 (16.95%)  10
non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post-baseline)  [2]  29/60 (48.33%)  29 27/59 (45.76%)  27
Indicates events were collected by systematic assessment
[1]
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
[2]
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.
The inclusion of a larger number of patients in this study may have uncovered differences in the efficacy outcomes studied between the groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Fabio Pereira Muchão
Organization: University of Sao Paulo
Phone: +5511 983835563
Responsible Party: Luiz Vicente Ribeiro Ferreira da Silva Filho, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01323010     History of Changes
Other Study ID Numbers: Hidalba
First Submitted: March 24, 2011
First Posted: March 25, 2011
Results First Submitted: September 14, 2015
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016