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

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

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

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Primary:

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

5.  Primary:

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

6.  Primary:

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

7.  Primary:

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

8.  Primary:

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

9.  Primary:

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

10.  Primary:

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

11.  Primary:

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

12.  Primary:

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

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 ]

14.  Primary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

19.  Secondary:

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

20.  Secondary:

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

21.  Post-Hoc:

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

22.  Post-Hoc:

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

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 ]

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 ]