A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 HFA Versus Fluticasone Propionate 100 HFA In Children With Asthma

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00441441

First received: February 28, 2007

Last updated: August 30, 2010

Last verified: August 2010

History of Changes

Results First Received: January 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: fluticasone propionate 100mcg HFA Drug: fluticasone propionate/salmeterol 100/50mcg 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
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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
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)	Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 mcg HFA (2 inhalations of 50/25 mcg), twice daily for 12 weeks.
Fluticasone Propionate HFA	Participants who were randomly assigned to Fluticasone Propionate 100 mcg HFA (2 inhalations of 50 mcg), twice daily for 12 weeks.

Participant Flow: Overall Study

	Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)	Fluticasone Propionate HFA
STARTED	173	177
COMPLETED	162	163
NOT COMPLETED	11	14
Adverse Event	2	1
Protocol Violation	4	6
Exacerbation of asthma	1	2
Withdrawal by Subject	1	2
Not specified	3	3

Baseline Characteristics

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Reporting Groups

	Description
Fluticasone Propionate/Salmeterol HFA	Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 mcg HFA (2 inhalations of 50/25 mcg), twice daily for 12 weeks.
Fluticasone Propionate HFA	Participants who were randomly assigned to Fluticasone Propionate 100 mcg HFA (2 inhalations of 50 mcg), twice daily for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Fluticasone Propionate/Salmeterol HFA	Fluticasone Propionate HFA	Total
Number of Participants [units: participants]	173	177	350
Age, Customized [units: participants]
4-5 years	36	41	77
6-11 years	137	136	273
Gender [units: participants]
Female	66	71	137
Male	107	106	213
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	70	73	143
Not Hispanic or Latino	103	104	207
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized [units: participants]
White/Caucasian/European Heritage	114	113	227
American Indian or Alaska Native	24	27	51
Central/South Asian Heritage	8	8	16
African American/African Heritage	7	8	15
Japanese Heritage	3	0	3
Arabic/North African Heritage	2	2	4
South East Asian Heritage	2	0	2
Mixed Race	13	19	32

Outcome Measures

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1. Primary:

Possible Drug-Related Adverse Events [ Time Frame: Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug) ]

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2. Primary:

Investigator Evaluations of Electrocardiogram (ECG) Results [ Time Frame: Baseline and Week 12 ]

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3. Primary:

Clinically Significant Unfavorable ECGs at Week 12 [ Time Frame: Baseline, Week 12 ]

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4. Primary:

ECG Measures – Heart Rate [ Time Frame: Baseline and Week 12 ]

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5. Primary:

ECG Measures - QT Interval [ Time Frame: Baseline and Week 12 ]

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6. Primary:

Cardiovascular Adverse Events Reported During Treatment Period [ Time Frame: 12-Week Treatment Period ]

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7. Primary:

Cardiovascular Adverse Events Reported During the Post-Treatment Period [ Time Frame: 5 Days after Week 12 ]

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8. Primary:

Asthma Exacerbations [ Time Frame: Treatment period (weeks 1-12) ]

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9. Primary:

Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion [ Time Frame: Baseline and week 12 ]

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10. Primary:

Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]

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11. Primary:

Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion [ Time Frame: Baseline and Week 12 ]

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12. Primary:

Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use [ Time Frame: Baseline and Week 12 ]

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13. Primary:

Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]

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14. Primary:

Geometric Mean Ratio for Week12:Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use [ Time Frame: Baseline and Week 12 ]

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15. Secondary:

Clinic AM Forced Expiratory Volume in Participants 6-11 Years [ Time Frame: Baseline and week 12 ]

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16. Secondary:

AM Peak Expiratory Flow [ Time Frame: Baseline and 12-Week Treatment Period ]

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17. Secondary:

Asthma Symptom Scores [ Time Frame: Baseline and 12-Week Treatment Period ]

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18. Secondary:

Percentage of Symptom Free Days [ Time Frame: Baseline and 12-Week Treatment Period ]

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19. Secondary:

Albuterol Use [ Time Frame: Baseline and 12-Week Treatment Period ]

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Measure Type	Secondary
Measure Title	Albuterol Use
Measure Description	Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.
Time Frame	Baseline and 12-Week Treatment Period
Safety Issue	No

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.
Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.

Reporting Groups

	Description
Fluticasone Propionate/Salmeterol HFA	Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 mcg HFA (2 inhalations of 50/25 mcg), twice daily for 12 weeks.
Fluticasone Propionate HFA	Participants who were randomly assigned to Fluticasone Propionate 100 mcg HFA (2 inhalations of 50 mcg), twice daily for 12 weeks.

Measured Values

	Fluticasone Propionate/Salmeterol HFA	Fluticasone Propionate HFA
Number of Participants Analyzed [units: participants]	173	177
Albuterol Use [units: Number of puffs per 24 hours] Mean ± Standard Error
Baseline - Mean number of puffs	1.5 ± 0.12	1.8 ± 0.19
Weeks 1-12 - Mean number of puffs	1.0 ± 0.09	0.9 ± 0.09
Weeks 1-12 – Mean change from baseline	-0.6 ± 0.12	-1.0 ± 0.16
Last 7 Days on Treatment - Mean number of puffs	0.7 ± 0.11	0.7 ± 0.11
Last 7 Days on Treat. - Mean change from baseline	0.15 ± -0.8	-1.2 ± 0.19

No statistical analysis provided for Albuterol Use

20. Secondary:

Percent of Albuterol-free Days [ Time Frame: Baseline and 12-Week Treatment Period ]

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21. Post-Hoc:

Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]

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22. Post-Hoc:

Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion [ Time Frame: Baseline and Week 12 ]

Show Outcome Measure 22

23. Post-Hoc:

Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]

Show Outcome Measure 23

24. Post-Hoc:

Geometric Mean Ratio for Baseline:Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population [ Time Frame: Baseline and Week 12 ]

Show Outcome Measure 24

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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
A post-hoc evaluation confirmed that no clinically relevant ECG abnormalities were present. Differences in the primary and post-hoc analyses were associated with variation in the method of ECG interpretation and are not fully interpretable.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Li JS, Qaqundah PY, Weinstein SF, LaForce CF, Ellsworth AV, Ortega HG, Ferro TJ. Fluticasone propionate/salmeterol combination in children with asthma: key cardiac and overall safety results. Clin Res Reg Affairs 2010;27(3):87-95.

ClinicalTrials.gov Identifier:	NCT00441441 History of Changes
Other Study ID Numbers:	SFA106484
Study First Received:	February 28, 2007
Results First Received:	January 23, 2009
Last Updated:	August 30, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration

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