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Clinical Trial Results:
A study to compare GW815SF HFA MDI with concomitant treatment with salmeterol xinafoate DPI plus fluticasone propionate DPI and to assess long-term safety of GW815SF HFA MDI.

Summary
EudraCT number	2015-004882-10
Trial protocol	Outside EU/EEA
Global end of trial date	19 Jan 2008

Results information
Results version number	v1(current)
This version publication date	14 Jan 2017
First version publication date	14 Jan 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

110099

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

14 Mar 2008

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

19 Jan 2008

Was the trial ended prematurely?

Main objective of the trial

TBD

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

02 Apr 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 52

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 51 participants were randomized to the crossover period, out of which 50 completed the extension period.

Period 1 title

Overall study

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

SFC 50/100 mcg/day First

Arm description

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).

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

SLM 50 mcg + FP 100 mcg/day First

Arm description

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).

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

Number of subjects in period 1 ^[1]	SFC 50/100 mcg/day First	SLM 50 mcg + FP 100 mcg/day First
Started	26	25
Completed	25	25
Not completed	1	0
other	1	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 52 participants were enrolled and 51 participants were randomized.

Period 2 title

Treatment Period I - 4 weeks

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

SFC 50/100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

SLM 50 mcg + FP 100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

Number of subjects in period 2	SFC 50/100 mcg/day First	SLM 50 mcg + FP 100 mcg/day First
Started	26	25
Completed	26	25

Period 3 title

Washout Period-2 weeks

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

SFC 50/100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

SLM 50 mcg + FP 100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

Number of subjects in period 3	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	-

Period 4 title

Treatment Period II - 4 weeks

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

SFC 50/100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

SLM 50 mcg + FP 100 mcg/day First

Arm description

Arm type

Active comparator

Investigational medicinal product name

GW815SF (Salmeterol/Fluticasone propionate combination[SFC]) 25/50 microgram (mcg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

GW815SF (SLM) 25/50mcg twice daily via Metered dose inhaler (MDI).

Investigational medicinal product name

Fluticasone propionate (FP) 50mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

FP 50mcg twice daily via DPI

Investigational medicinal product name

Salmeterol (SLM) 25mcg

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

SLM 25 mcg twice daily via Dry powder inhaler (DPI)

Number of subjects in period 4	SFC 50/100 mcg/day First	SLM 50 mcg + FP 100 mcg/day First
Started	25	25
Completed	25	25

Baseline characteristics

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Reporting group title

Overall study

Reporting group description

Overall study

Reporting group values	Overall study	Total
Number of subjects	51
Age categorical
Units: Subjects
Age continuous
Age continuous description
Units: years
arithmetic mean (standard deviation)	8.3 ( 2.41 )	-
Gender categorical
Gender categorical description
Units: Subjects
Female	17	17
Male	34	34
Race/Ethnicity, Customized
Units: Subjects
Asian-Japanese Heritage	51	51
Region of Enrollment
Units: Subjects
Japan	51	51

End points

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Reporting group title

SFC 50/100 mcg/day First

Reporting group description

Reporting group title

SLM 50 mcg + FP 100 mcg/day First

Reporting group description

Reporting group title

SFC 50/100 mcg/day First

Reporting group description

Reporting group title

SLM 50 mcg + FP 100 mcg/day First

Reporting group description

Reporting group title

SFC 50/100 mcg/day First

Reporting group description

Reporting group title

SLM 50 mcg + FP 100 mcg/day First

Reporting group description

Reporting group title

SFC 50/100 mcg/day First

Reporting group description

Reporting group title

SLM 50 mcg + FP 100 mcg/day First

Reporting group description

Subject analysis set title

SFC 50/100mcg/day

Subject analysis set type

Per protocol

Subject analysis set description

Per Protocol Set who received GW815SF (SFC , Salmeterol/Fluticasone propionate combination) HFA (HydroFluoroAlkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Subject analysis set title

SLM 50mcg + FP 100mcg/day

Subject analysis set type

Per protocol

Subject analysis set description

Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate ) DPI 50 mcg twice daily

Subject analysis set title

SFC 50/100 MCG/DAY

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set who received GW815SF (SFC , Salmeterol/Fluticasone propionate combination) HFA (HydroFluoroAlkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Primary: Adjusted Mean Change from Baseline in Morning PEF (Peak Expiratory Flow) during the 4-week Treatment Periods

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End point title

Adjusted Mean Change from Baseline in Morning PEF (Peak Expiratory Flow) during the 4-week Treatment Periods

End point description

Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).

End point type

Primary

End point timeframe

Crossover Period Weeks 1-4, and 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[1]	48 ^[2]
Units: Liters/minute
arithmetic mean (standard error)	14.3 ( 4.53 )	17.1 ( 4.53 )

Notes
[1] - PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.
[2] - PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.

Statistical analysis 1

Statistical analysis description

Difference between treatments [(SLM + FP)- SFC](SE) 2.8 (5.91)

Comparison groups

SFC 50/100mcg/day v SLM 50mcg + FP 100mcg/day

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

equivalence ^[3]

P-value

= 0.6383 ^[4]

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-9.1

upper limit

14.69

Variability estimate

Standard error of the mean

Dispersion value

5.91

Notes
[3] - Equivalence margin + or - 15 L/min
[4] - Confidence Interval

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 4-week Treatment Periods

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End point title

Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 4-week Treatment Periods

End point description

End point type

Secondary

End point timeframe

Crossover Period Weeks 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[5]	48 ^[6]
Units: Percentage of predicted value
arithmetic mean (standard error)	5.38 ( 1.543 )	6.73 ( 1.543 )

Notes
[5] - PPS
[6] - PPS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 4-week Treatment Periods

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End point title

Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 4-week Treatment Periods

End point description

End point type

Secondary

End point timeframe

Crossover Period weeks 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[7]	48 ^[8]
Units: Percentage of personal best value
arithmetic mean (standard error)	5.01 ( 1.48 )	6.46 ( 1.48 )

Notes
[7] - PPS
[8] - PPS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 4-week Treatment Periods

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End point title

Adjusted Mean Change from Baseline in Evening PEF during the 4-week Treatment Periods

End point description

End point type

Secondary

End point timeframe

Crossover Period weeks 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[9]	48 ^[10]
Units: L/min
arithmetic mean (standard error)	16.3 ( 3.74 )	15.8 ( 3.74 )

Notes
[9] - PPS
[10] - PPS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in Morning PEF(%) during the 4-week Treatment Periods

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End point title

Adjusted Mean Change from Baseline of Circadian Variation in Morning PEF(%) during the 4-week Treatment Periods

End point description

End point type

Secondary

End point timeframe

Crossover Period Weeks 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[11]	48 ^[12]
Units: Percentage of circadian variation
arithmetic mean (standard error)	0.06 ( 0.638 )	-0.08 ( 0.638 )

Notes
[11] - PPS
[12] - PPS

No statistical analyses for this end point

Secondary: Percentage of Subjects with Symptom-Free Nights & Days

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End point title

Percentage of Subjects with Symptom-Free Nights & Days

End point description

Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment

End point type

Secondary

End point timeframe

Crossover Period Week 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[13]	48 ^[14]
Units: Percent of participants
number (not applicable)
Baseline	72.9	81.3
After 4 Weeks of Treatment	91.7	81.3

Notes
[13] - PPS
[14] - PPS

No statistical analyses for this end point

Secondary: Percentage of Subjects with Rescue Medication-Free Nights and Days

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End point title

Percentage of Subjects with Rescue Medication-Free Nights and Days

End point description

Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment

End point type

Secondary

End point timeframe

Crossover Period Weeks 1-4, 7-10

End point values	SFC 50/100mcg/day	SLM 50mcg + FP 100mcg/day
Number of subjects analysed	48 ^[15]	48 ^[16]
Units: Percentage of participants
number (not applicable)
Baseline	87.5	87.5
After 4 Weeks of Treatment	93.8	87.5

Notes
[15] - PPS
[16] - PPS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Morning PEF during the 20-week Extension Treatment Period

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End point title

Adjusted Mean Change from Baseline in Morning PEF during the 20-week Extension Treatment Period

End point description

Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30). FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

End point type

Secondary

End point timeframe

Extension Period Weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[17]
Units: L/min
arithmetic mean (standard deviation)	3 ( 24.56 )

Notes
[17] - FAS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 20-Week Extension Treatment Period

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End point title

Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 20-Week Extension Treatment Period

End point description

Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30). FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

End point type

Secondary

End point timeframe

Extension Period weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[18]
Units: Percentage of predicted value
arithmetic mean (standard deviation)	1.46 ( 9.568 )

Notes
[18] - FAS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 20-week Extension Treatment Period

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End point title

Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 20-week Extension Treatment Period

End point description

End point type

Secondary

End point timeframe

Extension Period weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[19]
Units: Percentage of personal best value
arithmetic mean (standard deviation)	1.29 ( 8.541 )

Notes
[19] - FAS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in PEF(%) during the 20-Week Extension Treatment Period

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End point title

Adjusted Mean Change from Baseline of Circadian Variation in PEF(%) during the 20-Week Extension Treatment Period

End point description

End point type

Secondary

End point timeframe

Extension Period weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[20]
Units: Percentage of circadian variation
arithmetic mean (standard deviation)	2.7 ( 23.43 )

Notes
[20] - FAS

No statistical analyses for this end point

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 20-week Extension Treatment Period

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End point title

Adjusted Mean Change from Baseline in Evening PEF during the 20-week Extension Treatment Period

End point description

End point type

Secondary

End point timeframe

Extension Period weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[21]
Units: L/Min
arithmetic mean (standard deviation)	-0.37 ( 3.568 )

Notes
[21] - FAS

No statistical analyses for this end point

Secondary: Percentage of Subjects with Symptom-Free Nights & Days after 20 Weeks of Treatment

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End point title

Percentage of Subjects with Symptom-Free Nights & Days after 20 Weeks of Treatment

End point description

Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30). FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

End point type

Secondary

End point timeframe

Extension Period Weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[22]
Units: Percentage of participants
number (not applicable)
Baseline	84
After 20 weeks of treatment (at week 30)	84.8

Notes
[22] - FAS

No statistical analyses for this end point

Secondary: Percentage of Subjects with Rescue Medication-Free Nights & Days after 20 Weeks of Treatment

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End point title

Percentage of Subjects with Rescue Medication-Free Nights & Days after 20 Weeks of Treatment

End point description

Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30). FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

End point type

Secondary

End point timeframe

Extension Period Weeks 11-30

End point values	SFC 50/100 MCG/DAY
Number of subjects analysed	50 ^[23]
Units: Percentage of participants
number (not applicable)
Baseline	90
After 20 weeks of treatment (at week 30)	89.1

Notes
[23] - FAS

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From Baseline to Week 32

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

SFC 50/100 mcg/day

Reporting group description

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

Reporting group title

SFC 50/100mcg/day (Extension Period)

Reporting group description

Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period

Reporting group title

SLM 50 + FP 100 mcg/day

Reporting group description

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

Serious adverse events	SFC 50/100 mcg/day	SFC 50/100mcg/day (Extension Period)	SLM 50 + FP 100 mcg/day
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 51 (0.00%)	0 / 50 (0.00%)	0 / 50 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	SFC 50/100 mcg/day	SFC 50/100mcg/day (Extension Period)	SLM 50 + FP 100 mcg/day
Total subjects affected by non serious adverse events
subjects affected / exposed	9 / 51 (17.65%)	35 / 50 (70.00%)	7 / 50 (14.00%)
Gastrointestinal disorders
Stomatitis
alternative dictionary used: MedDRA 10
subjects affected / exposed	0 / 51 (0.00%)	3 / 50 (6.00%)	0 / 50 (0.00%)
occurrences all number	0	4	0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract inflammation
alternative dictionary used: MedDRA 10
subjects affected / exposed	7 / 51 (13.73%)	17 / 50 (34.00%)	3 / 50 (6.00%)
occurrences all number	10	30	4
Asthma
alternative dictionary used: MedDRA 10
subjects affected / exposed	0 / 51 (0.00%)	5 / 50 (10.00%)	0 / 50 (0.00%)
occurrences all number	0	8	0
Skin and subcutaneous tissue disorders
Eczema
alternative dictionary used: MedDRA 10
subjects affected / exposed	0 / 51 (0.00%)	4 / 50 (8.00%)	0 / 50 (0.00%)
occurrences all number	0	4	0
Infections and infestations
Nasopharyngitis
alternative dictionary used: MedDRA 10.0
subjects affected / exposed	2 / 51 (3.92%)	7 / 50 (14.00%)	4 / 50 (8.00%)
occurrences all number	2	10	4
Gastroenteritis
alternative dictionary used: MedDRA 10
subjects affected / exposed	0 / 51 (0.00%)	7 / 50 (14.00%)	0 / 50 (0.00%)
occurrences all number	0	8	0

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A study to compare GW815SF HFA MDI with concomitant treatment with salmeterol xinafoate DPI plus fluticasone propionate DPI and to assess long-term safety of GW815SF HFA MDI.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Adjusted Mean Change from Baseline in Morning PEF (Peak Expiratory Flow) during the 4-week Treatment Periods

Primary: Adjusted Mean Change from Baseline in Morning PEF (Peak Expiratory Flow) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in Morning PEF(%) during the 4-week Treatment Periods

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in Morning PEF(%) during the 4-week Treatment Periods

Secondary: Percentage of Subjects with Symptom-Free Nights & Days

Secondary: Percentage of Subjects with Symptom-Free Nights & Days

Secondary: Percentage of Subjects with Rescue Medication-Free Nights and Days

Secondary: Percentage of Subjects with Rescue Medication-Free Nights and Days

Secondary: Adjusted Mean Change from Baseline in Morning PEF during the 20-week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Morning PEF during the 20-week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 20-Week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 20-Week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 20-week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 20-week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in PEF(%) during the 20-Week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline of Circadian Variation in PEF(%) during the 20-Week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 20-week Extension Treatment Period

Secondary: Adjusted Mean Change from Baseline in Evening PEF during the 20-week Extension Treatment Period

Secondary: Percentage of Subjects with Symptom-Free Nights & Days after 20 Weeks of Treatment

Secondary: Percentage of Subjects with Symptom-Free Nights & Days after 20 Weeks of Treatment

Secondary: Percentage of Subjects with Rescue Medication-Free Nights & Days after 20 Weeks of Treatment

Secondary: Percentage of Subjects with Rescue Medication-Free Nights & Days after 20 Weeks of Treatment

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A study to compare GW815SF HFA MDI with concomitant treatment with salmeterol xinafoate DPI plus fluticasone propionate DPI and to assess long-term safety of GW815SF HFA MDI.