Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics - Study Results

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

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
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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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Reporting Groups

	Description
Albuterol	Albuterol-HFA-MDI 180 mcg, four times a day
Placebo	Placebo-HFA-MDI

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:

The Maximum Percent Change From Baseline in the Forced Expiratory Volume in One Second (FEV1) Observed up to 2 Hours Following Completion of Dosing Using Day 22 Baseline [ Time Frame: Day 1, Day 22, up to 2 hours following completion of dosing on Day 22 ]

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2. Primary:

Maximum Percent Change in Peak Expiratory Flow (PEF) Observed up to 2 Hours Following Completion of Dosing Using Day 22 Baseline. [ Time Frame: Day 22 ]

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3. Secondary:

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

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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 ]

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5. Secondary:

Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose. [ Time Frame: Day 1, Day 22 ]

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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 1, Day 22, Day 22 with LOCF ]

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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 1, Day 22, day 22 with LOCF ]

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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 1, Day 22, day 22 with LOCF ]

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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 1, Day 22, Day 22 with LOCF ]

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10. Secondary:

The Time (in Minutes) to Maximum FEVl [ Time Frame: Day 1, Day 22 with LOCF ]

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11. Secondary:

The Time (in Minutes) to Maximum PEF [ Time Frame: Day 1, Day 22 with LOCF ]

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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 1, Day 22, Day 22 with LOCF ]

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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 1, Day 22, Day 22 with LOCF ]

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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 1, Day 22, Day 22 with LOCF ]

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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 1, Day 22 , day 22 with LOCF ]

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16. Secondary:

Highest Daily Asthma Symptom Scores by Study Week [ Time Frame: Week 1, Week 2, Week 3 ]

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17. Secondary:

The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication [ Time Frame: Week 1, Week 2, Week 3 ]

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18. Secondary:

The Daily a.m. Pre-dose PEF [ Time Frame: Week 1, Week 2, Week 3 ]

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19. Secondary:

The Average Number of Puffs of Rescue Medication Per 24 Hour Period [ Time Frame: Week 1, Week 2, Week 3 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor has the right 60 days before submission for publication to review/provide comments. If review shows that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for up to 90 additional days to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure of multicenter data, but not longer than 12 months from study completion/termination at all participating sites.

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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Ivax Research, LLC
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:	October 27, 2009
Health Authority:	United States: Food and Drug Administration