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Albuterol HFA MDI in Pediatric Participants With Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577655
First Posted: December 20, 2007
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Results First Submitted: July 21, 2009  
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: Albuterol
Drug: Placebo
Drug: Proventil® HFA

  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
208 individual subjects were screened; ten subjects failed the initial screening but were later re-screened and successfully enrolled.

Reporting Groups
  Description
Albuterol Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
Placebo Placebo HFA-MDI four times a day for 21 days.

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 (total daily albuterol dose of 720 mcg) for 21 days.
Placebo Placebo HFA-MDI four times a day for 21 days.
Total Total of all reporting groups

Baseline Measures
   Albuterol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   51   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.3  (1.82)   8.2  (2.09)   8.2  (1.95) 
Gender 
[Units: Participants]
     
Female   19   20   39 
Male   33   31   64 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   30   39   69 
Black   14   7   21 
Asian   5   3   8 
North American Indian or Alaska native   1   1   2 
Other   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   52   51   103 
Forced Expiratory Volume in One Second (FEV1) on Day 1 [1] 
[Units: Liters]
Mean (Standard Deviation)
 1.52  (0.38)   1.49  (0.46)   1.50  (0.42) 
[1] Baseline measurement is the average of two Day 1 pre-dose FEV1 values. n=51, 51, 103


  Outcome Measures
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1.  Primary:   Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22   [ Time Frame: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation ]

2.  Primary:   Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22   [ Time Frame: 30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation ]

3.  Secondary:   Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing ]

4.  Secondary:   Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases   [ Time Frame: Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing ]

5.  Secondary:   Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines   [ Time Frame: Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation) ]

6.  Secondary:   Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines   [ Time Frame: Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation ]

7.  Secondary:   Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)   [ Time Frame: Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing ]

8.  Secondary:   Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing ]

9.  Secondary:   Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22   [ Time Frame: Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing ]

10.  Secondary:   Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing ]

11.  Secondary:   Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing ]

12.  Secondary:   Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing ]

13.  Secondary:   Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22   [ Time Frame: Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing ]

14.  Secondary:   Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3   [ Time Frame: Weeks 1, 2, 3 ]

15.  Secondary:   The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication   [ Time Frame: Run-in (Days -21 to -1), Weeks 1, 2, 3 ]

16.  Secondary:   Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning   [ Time Frame: Weeks 1, 2, 3 ]

17.  Secondary:   Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3   [ Time Frame: Weeks 1, 2, 3 ]


  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: Teva Study Physician
Organization: Teval Global Respiratory Research LLC
phone: 215-293-6482



Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00577655     History of Changes
Other Study ID Numbers: IXR-302-25-105
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: July 21, 2009
Results First Posted: December 3, 2009
Last Update Posted: October 25, 2016