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Trial record 48 of 858 for:    ALBUTEROL

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

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ClinicalTrials.gov Identifier: NCT00124176
Recruitment Status : Completed
First Posted : July 27, 2005
Results First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Racemic albuterol (R+S albuterol)
Drug: Levalbuterol (R albuterol)
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization Continuous racemic albuterol 20mg/hr given as continuous nebulization
Period Title: Overall Study
Started 40 41
Received Study Drug 37 [1] 41
Completed 40 41
Not Completed 0 0
[1]
3 never started on drug due to improvement but were kept in the study by intention to treat.
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol Total
Hide Arm/Group Description Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization Continuous racemic albuterol 20mg/hr given as continuous nebulization Total of all reporting groups
Overall Number of Baseline Participants 40 41 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
<=18 years
40
 100.0%
41
 100.0%
81
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 81 participants
10.4  (3.5) 10.7  (3.3) 10.6  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
Female
14
  35.0%
16
  39.0%
30
  37.0%
Male
26
  65.0%
25
  61.0%
51
  63.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 41 participants 81 participants
40 41 81
1.Primary Outcome
Title Duration of Continuous Therapy
Hide Description standard intention to treat (ITT) analysis
Time Frame During hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description:
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous racemic albuterol 20mg/hr given as continuous nebulization
Overall Number of Participants Analyzed 40 41
Median (Inter-Quartile Range)
Unit of Measure: Hours
18.3
(11 to 25)
16
(11 to 25)
2.Secondary Outcome
Title Change in Pediatric Asthma Severity Score
Hide Description

Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)

Score at each time point is calculated by adding 3 elements:

Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)

Time Frame After 12 hours of continuous nebulization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description:
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous racemic albuterol 20mg/hr given as continuous nebulization
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (1.2) -0.64  (1.7)
3.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame After 12 hours of continuous nebulization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description:
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous racemic albuterol 20mg/hr given as continuous nebulization
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: beats per minute
132  (16.4) 132  (18.4)
4.Secondary Outcome
Title Serum Potassium Levels
Hide Description [Not Specified]
Time Frame After 12 hours of continuous nebulization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description:
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous racemic albuterol 20mg/hr given as continuous nebulization
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
3.6  (0.6) 3.6  (0.4)
5.Secondary Outcome
Title Serum Albuterol S Isomer Levels
Hide Description [Not Specified]
Time Frame After 6 hours of continuous albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description:
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous racemic albuterol 20mg/hr given as continuous nebulization
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.5  (3.3) 28.6  (11.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Hide Arm/Group Description Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization Continuous racemic albuterol 20mg/hr given as continuous nebulization
All-Cause Mortality
Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Continuous Levalbuterol (R) Nebulized Solution Continuous Racemic (R+S) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/41 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Joseph Zorc, MD
Organization: Children's Hospital of Philadelphia
Phone: 215-590-1944
EMail: zorc@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00124176     History of Changes
Other Study ID Numbers: #2004-12-4130
First Submitted: July 25, 2005
First Posted: July 27, 2005
Results First Submitted: July 14, 2010
Results First Posted: March 14, 2013
Last Update Posted: March 14, 2013