Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00577655
First received: December 18, 2007
Last updated: April 11, 2012
Last verified: April 2012
Results First Received: July 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Albuterol
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
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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
Albuterol Albuterol-HFA-MDI 180 mcg, four times a day
Placebo Placebo-HFA-MDI

Participant Flow:   Overall Study
    Albuterol     Placebo  
STARTED     52 [1]   51 [1]
COMPLETED     51     47  
NOT COMPLETED     1     4  
Patient Request                 0                 2  
Protocol Violation                 0                 1  
Lost to Follow-up                 1                 1  
[1] This number represents the number of participants randomized.



  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.
No text entered.

Reporting Groups
  Description
Albuterol Albuterol-HFA-MDI 180 mcg, four times a day
Placebo Placebo-HFA-MDI
Total Total of all reporting groups

Baseline Measures
    Albuterol     Placebo     Total  
Number of Participants  
[units: participants]
  52     51     103  
Age  
[units: Years]
Mean ± Standard Deviation
     
Age     8.3  ± 1.82     8.2  ± 2.09     8.2  ± 1.95  
Gender  
[units: participants]
     
Female     19     20     39  
Male     33     31     64  
Region of Enrollment  
[units: participants]
     
United States     52     51     103  



  Outcome Measures
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1.  Primary:   Maximum Percent Change From Baseline   [ Time Frame: 2 hours following completion of dosing on Day 22 ]

2.  Primary:   Maximum Percent Change in Peak Expiratory Flow (PEF)   [ Time Frame: Day 22 ]

3.  Secondary:   Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose   [ Time Frame: Day 1 ]

4.  Secondary:   Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22.   [ Time Frame: Day 22 ]

5.  Secondary:   Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose.   [ Time Frame: Day 22 ]

6.  Secondary:   The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 15% is Noted in Participants Who Responded to the Medication.   [ Time Frame: Day 22 ]

7.  Secondary:   The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted   [ Time Frame: Day 22 ]

8.  Secondary:   The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted   [ Time Frame: Day 22 ]

9.  Secondary:   The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted   [ Time Frame: Day 22 ]

10.  Secondary:   The Time (in Minutes) to Maximum FEVl   [ Time Frame: Day 22 ]

11.  Secondary:   The Time (in Minutes) to Maximum PEF   [ Time Frame: Day 22 ]

12.  Secondary:   The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15%   [ Time Frame: Day 22 ]

13.  Secondary:   The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12%   [ Time Frame: Day 22 ]

14.  Secondary:   The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15%   [ Time Frame: Day 22 ]

15.  Secondary:   The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12%   [ Time Frame: Day 22 ]

16.  Secondary:   Highest Daily Asthma Symptom Scores by Study Week   [ Time Frame: Week 3 ]

17.  Secondary:   The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication   [ Time Frame: Week 3 ]

18.  Secondary:   The Daily a.m. Pre-dose PEF   [ Time Frame: Week 3 ]

19.  Secondary:   The Average Number of Puffs of Rescue Medication Per 24 Hour Period   [ Time Frame: Week 3 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Teva Study Physician
Organization: Teval Global Respiratory Research LLC
phone: 215-293-6482


No publications provided


Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00577655     History of Changes
Other Study ID Numbers: IXR-302-25-105
Study First Received: December 18, 2007
Results First Received: July 21, 2009
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration