Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Condition:	Bronchial Asthma
Interventions:	Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate

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
SFC 50/100 Mcg/Day First	GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
SLM 50 Mcg + FP 100 Mcg/Day First	SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).

Participant Flow for 4 periods

Period: Treatment Period I - 4 Weeks

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	26	25
COMPLETED	26	25
NOT COMPLETED	0	0

Period: Washout Period - 2 Weeks

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	26	25
COMPLETED	25	25
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Period: Treatment Period II - 4 Weeks

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Period: Extension Period - 20 Weeks

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	50	0
COMPLETED	50	0
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall Study Population	Randomized Population

Baseline Measures

	Overall Study Population
Number of Participants [units: participants]	51
Age [units: Years] Mean ± Standard Deviation	8.3 ± 2.41
Gender [units: participants]
Female	17
Male	34
Race/Ethnicity, Customized [units: Participants]
Asian-Japanese Heritage	51
Region of Enrollment [units: participants]
Japan	51

Outcome Measures

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1. Primary:

Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, and 7-10 ]

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2. Secondary:

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, 7-10 ]

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3. Secondary:

Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period weeks 1-4, 7-10 ]

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4. Secondary:

Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [ Crossover Period weeks 1-4, 7-10 ]

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5. Secondary:

Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods [ Crossover Period Weeks 1-4, 7-10 ]

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6. Secondary:

Percentage of Subjects With Symptom-Free Nights & Days [ Crossover Period Week 1-4, 7-10 ]

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7. Secondary:

Percentage of Subjects With Rescue Medication-Free Nights and Days [ Crossover Period Weeks 1-4, 7-10 ]

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8. Secondary:

Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [ Extension Period Weeks 11-30 ]

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9. Secondary:

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [ Extension Period weeks 11-30 ]

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10. Secondary:

Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period [ Extension Period weeks 11-30 ]

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11. Secondary:

Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [ Extension Period weeks 11-30 ]

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12. Secondary:

Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [ Extension Period weeks 11-30 ]

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13. Secondary:

Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [ Extension Period Weeks 11-30 ]

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14. Secondary:

Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [ Extension Period Weeks 11-30 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
SLM 50 + FP 100 Mcg/Day	Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
SFC 50/100mcg/Day (Extension Period)	Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period

Other Adverse Events

	SFC 50/100 Mcg/Day	SLM 50 + FP 100 Mcg/Day	SFC 50/100mcg/Day (Extension Period)
Total, other (not including serious) adverse events
# participants affected / at risk	12	10	35
Gastrointestinal disorders
Stomatitis ^†^A # participants affected / at risk	2/51 (3.92%)	0/50 (0.00%)	3/50 (6.00%)
Infections and infestations
Nasopharyngitis ^†^B # participants affected / at risk	2/51 (3.92%)	4/50 (8.00%)	7/50 (14.00%)
Gastroenteritis ^†^A # participants affected / at risk	1/51 (1.96%)	2/50 (4.00%)	7/50 (14.00%)
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract inflammation ^†^A # participants affected / at risk	7/51 (13.73%)	3/50 (6.00%)	17/50 (34.00%)
Asthma ^†^A # participants affected / at risk	1/51 (1.96%)	1/50 (2.00%)	5/50 (10.00%)
Skin and subcutaneous tissue disorders
Eczema ^†^A # participants affected / at risk	0/51 (0.00%)	0/50 (0.00%)	4/50 (8.00%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10
^B	Term from vocabulary, MedDRA 10.0

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 an 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 preceed 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110099
Study First Received:	March 14, 2007
Results First Received:	January 19, 2009
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00448435 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare