A Safety, Efficacy and Tolerability Study in Pediatric Su... | NCT00809757

Status Module

Label	Type	Description	Intervention Names
1	Experimental	90 ug Levalbuterol (2 actuations)	Drug: Levalbuterol
2	Active Comparator	0.31 ug Levalbuterol UDV TID	Drug: Levalbuterol UDV TID
3	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Levalbuterol	Drug	90 ug Levalbuterol (2 actuations)	1	Xopenex HFA Inhalation Aerosol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.	Baseline, Visit 4 (Week 4)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment	The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).
Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.
Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma.
In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.
Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.

Exclusion Criteria:

Subject who requires or is expected to require any disallowed medications
Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.
Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.
Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
Subject who has experienced significant blood loss within 60 days of study drug.
Subject with a clinical diagnosis of cystic fibrosis.
Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening
Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000].
Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.
Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).
Subject with a history of cancer.
Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.
Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening.
Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry).
Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects.
Subject who is a relative of a staff member.

Name	Affiliation	Role
Respiratory Medical Director, MD	Sumitomo Pharma America, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Little Rock Allergy & Asthma Clinical Research Center		Little Rock	Arkansas	72205	United States

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Placebo: Placebo (2 actuations)
FG001	Levalbuterol MDI	90 ug Levalbuterol (2 actuations) Levalbuterol: 90 ug Levalbuterol (2 actuations)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00068 BG00165 BG00263 BG003

Age, Continuous

Median

Standard Deviation

Months

Title

Denominators

Categories

Title	Measurements
	BG00029.2± 12.17 BG00129.3± 12.57 BG002

Age, Customized

Number

participants

Title

Denominators

Categories

0 to < 12 months

Title	Measurements
	BG0009 BG0019 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00029 BG00135 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00016 BG00121 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00068 BG00165 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)

The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).

The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.

Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis

Posted

Mean

Standard Deviation

units on a scale

Baseline, Visit 4 (Week 4)

ID	Title	Description
OG000	Placebo	Placebo: Placebo (2 actuations)
OG001	Levalbuterol MDI	90 ug Levalbuterol (2 actuations) Levalbuterol: 90 ug Levalbuterol (2 actuations)
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG00062 OG00159 OG00254

Title

Denominators

Categories

Title	Measurements
	OG000-1.21± 2.722 OG001-0.67± 2.092 OG002-0.52± 2.843

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.					Mean Difference (Final Values)	-0.54			2-Sided	95	-1.412	0.342			Difference is Placebo MDI minus Levalbuterol UDV	No	Superiority or Other

Secondary

Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

Baseline, Visit 3 (Week 3)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts

Secondary

Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV 0.31 ug Levalbuterol UDV TID

Units

Secondary

Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV 0.31 ug Levalbuterol UDV TID

Units

Secondary

Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)

The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).

The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

Baseline, Visit 3 (Week 3)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units

Secondary

Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire

The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

Baseline, Visit 4 (Week 4)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV 0.31 ug Levalbuterol UDV TID

Units	Counts

Secondary

Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire

The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Secondary

Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire

The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

units on a scale

The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Secondary

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2

Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

liters

Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

liters

Baseline, Visit 3, pre-dose (approximately 14 days after randomization)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

liters

Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

percent change

Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

percent change

Baseline, Visit 3, pre -dose (approximately 14 days after randomization)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

percent change

Baseline, Visit 4, pre -dose (approximately 28 days after randomization)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4

Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

liters

Baseline, Visit 3 (the week prior to Visit 3) and Visit 4

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)

Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.

Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)

Posted

Mean

Standard Deviation

percent change

Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Investigator Global Assessment - Question 1

Since the start of the study, how would you evaluate the child's asthma symptoms?

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Investigator Global Assessment - Question 2

Since the start of the study, how would you evaluate your ability to manage the subject's asthma?

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Caregiver Global Assessment - Question 1

Since the start of the study, how would you evaluate your child's asthma symptoms?

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Caregiver Global Assessment - Question 2

Since the start of the study, how would you evaluate your ability to manage your child's asthma?

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Caregiver Global Assessment - Question 3

Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts

Secondary

Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period

Number of subjects using rescue medication during the treatment period

Intent-to-Treat Population

Posted

Number

Number of subjects

Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used

Intent-to-Treat Population - Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline

Posted

Mean

Standard Deviation

Days per Week

Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week

Intent-to-Treat Population

Posted

Mean

Standard Deviation

Doses per Week

Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants	OG000

Secondary

Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used

Intent-to-Treat Population - subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline

Posted

Mean

Standard Deviation

Doses per Week

Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Secondary

Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score

The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.

Intent-to-Treat Population

Posted

Mean

Standard Deviation

Units on a scale

Visit 3 and Visit 4 (End of 28 day treatment period)

ID	Title	Description
OG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID
OG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
OG002	Levalbuterol UDV	0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Metapneumovirus Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected65 at risk EG0020 events0 affected63 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0010 events0 affected65 at risk EG0021 events1 affected63 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0010 events0 affected65 at risk EG0021 events1 affected63 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0010 events0 affected65 at risk EG0022 events2 affected63 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected65 at risk EG0020 events0 affected63 at risk
Status Asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0011 events1 affected65 at risk EG0020 events0 affected63 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events2 affected65 at risk EG0020 events0 affected63 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected68 at risk EG0013 events3 affected65 at risk EG0022 events2 affected63 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected68 at risk EG0011 events1 affected65 at risk EG0021 events1 affected63 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events2 affected65 at risk EG0020 events0 affected63 at risk
Sinusitis Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected68 at risk EG0012 events2 affected65 at risk EG0020 events0 affected63 at risk
Tonsillitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected68 at risk EG0010 events0 affected65 at risk EG0020 events0 affected63 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0013 events3 affected65 at risk EG0020 events0 affected63 at risk
Dermatitis Diaper	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected68 at risk EG0012 events2 affected65 at risk EG0020 events0 affected63 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected68 at risk EG0012 events2 affected65 at risk EG0020 events0 affected63 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected68 at risk EG0018 events6 affected65 at risk EG0022 events2 affected63 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected68 at risk EG0013 events3 affected65 at risk EG0027 events7 affected63 at risk
Otitis Media	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events5 affected68 at risk EG0016 events5 affected65 at risk EG0028 events8 affected63 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected68 at risk EG0015 events5 affected65 at risk EG0025 events5 affected63 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected68 at risk EG0014 events4 affected65 at risk EG0022 events2 affected63 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected68 at risk EG0015 events4 affected65 at risk EG0020 events0 affected63 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

ID	Title	Description
BG000	Placebo	Placebo Placebo MDI TID
BG001	Levalbuterol MDI	Levalbuterol MDI TID
BG002	Levalbuterol UDV	Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	PBO MDI Placebo: Placebo (2 actuations) MDI TID	0	68	28	68
EG001	Levalbuterol MDI	LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID	1	65	31	65
EG002	Levalbuterol UDV	LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID	3	63	27	63