A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00809757
First received: December 15, 2008
Last updated: July 1, 2014
Last verified: July 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Levalbuterol
Drug: Levalbuterol UDV TID
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo: Placebo (2 actuations)
Levalbuterol MDI

90 ug Levalbuterol (2 actuations)

Levalbuterol: 90 ug Levalbuterol (2 actuations)

Levalbuterol UDV

0.31 ug Levalbuterol UDV TID

Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID


Participant Flow:   Overall Study
    Placebo     Levalbuterol MDI     Levalbuterol UDV  
STARTED     68     65     64  
COMPLETED     62     60     53  
NOT COMPLETED     6     5     11  
Adverse Event                 2                 3                 3  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 1                 1                 1  
Withdrawal by Subject                 2                 1                 3  
Subject Uncooperative                 1                 0                 2  
Noncompliance with Medication                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject was randomized but not dosed in the Levalbuterol UDV arm.

Reporting Groups
  Description
Placebo Placebo Placebo MDI TID
Levalbuterol MDI Levalbuterol MDI TID
Levalbuterol UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
Total Total of all reporting groups

Baseline Measures
    Placebo     Levalbuterol MDI     Levalbuterol UDV     Total  
Number of Participants  
[units: participants]
  68     65     63     196  
Age  
[units: participants]
       
<=18 years     68     65     63     196  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: Months]
Median ± Standard Deviation
  29.2  ± 12.17     29.3  ± 12.57     28.4  ± 12.48     29.0  ± 12.35  
Age, Customized  
[units: participants]
       
0 to < 12 months     9     9     9     27  
0 to < 24 months     23     23     22     68  
24 to < 48 months     45     42     41     128  
Gender  
[units: participants]
       
Female     29     35     24     88  
Male     39     30     39     108  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     16     21     19     56  
Not Hispanic or Latino     52     44     44     140  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     1     0     1  
Asian     0     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     18     23     24     65  
White     46     39     36     121  
More than one race     4     2     2     8  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     68     65     63     196  



  Outcome Measures
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1.  Primary:   Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)   [ Time Frame: Baseline, Visit 4 (Week 4) ]

2.  Secondary:   Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment   [ Time Frame: Baseline, Visit 3 (Week 3) ]

3.  Secondary:   Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment   [ Time Frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days ]

4.  Secondary:   Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment   [ Time Frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days ]

5.  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)   [ Time Frame: Baseline, Visit 3 (Week 3) ]

6.  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   [ Time Frame: Baseline, Visit 4 (Week 4) ]

7.  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   [ Time Frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days ]

8.  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   [ Time Frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days ]

9.  Secondary:   Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2   [ Time Frame: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose ]

10.  Secondary:   Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3   [ Time Frame: Baseline, Visit 3, pre–dose (approximately 14 days after randomization) ]

11.  Secondary:   Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4   [ Time Frame: 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 ]

12.  Secondary:   Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2   [ Time Frame: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose ]

13.  Secondary:   Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3   [ Time Frame: Baseline, Visit 3, pre –dose (approximately 14 days after randomization) ]

14.  Secondary:   Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4   [ Time Frame: Baseline, Visit 4, pre –dose (approximately 28 days after randomization) ]

15.  Secondary:   Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4   [ Time Frame: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4 ]

16.  Secondary:   Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)   [ Time Frame: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4) ]

17.  Secondary:   Investigator Global Assessment – Question 1   [ Time Frame: Visit 4 (End of 28 day treatment period) ]

18.  Secondary:   Investigator Global Assessment – Question 2   [ Time Frame: Visit 4 (End of 28 day treatment period) ]

19.  Secondary:   Caregiver Global Assessment – Question 1   [ Time Frame: Visit 4 (End of 28 day treatment period) ]

20.  Secondary:   Caregiver Global Assessment – Question 2   [ Time Frame: Visit 4 (End of 28 day treatment period) ]

21.  Secondary:   Caregiver Global Assessment – Question 3   [ Time Frame: Visit 4 (End of 28 day treatment period) ]

22.  Secondary:   Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period   [ Time Frame: 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) ]

23.  Secondary:   Rescue Medication Use – Change From Baseline in Mean Number of Days Used Per Week When Used   [ Time Frame: 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) ]

24.  Secondary:   Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week   [ Time Frame: 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) ]

25.  Secondary:   Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used   [ Time Frame: 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) ]

26.  Secondary:   Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLA) Composite Score   [ Time Frame: Visit 3 and Visit 4 (End of 28 day treatment period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Respiratory Medical Director
Organization: Sunovion
phone: 1-866-503-6351


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00809757     History of Changes
Other Study ID Numbers: 051-359
Study First Received: December 15, 2008
Results First Received: May 27, 2014
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration