CompletedNCT00448435Updated Jun 8, 2010Results posted

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

A Phase 3 interventional study of GW815SF HFA MDI and salmeterol and fluticasone propionate in Bronchial Asthma, sponsored by GlaxoSmithKline. Completed at 8 sites in Japan. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 51
Allocation: Randomized
Ages: 5 Years to 14 Years
Sex: All

Study summary

To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.

To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.

Conditions studied

Bronchial Asthma

Browse trials for

Asthma 3,921

Keywords

Salmeterol
Fluticasone propionate
Salmeterol/Fluticasone propionate combination
Pediatric bronchial asthma

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 51 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years to 14 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion criteria:

Inclusion Criteria for Entry in Run-in Period

A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:

Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of Treatment Period 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.
Written informed consent must be obtained from a legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.
An outpatient who has been treated with ICS (FP 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.
Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.

Inclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.

Has a mean of morning PEF measurements in the last 7 days of the run-in period (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .
Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment.
Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.

Exclusion criteria:

Exclusion Criteria for Entry in Run-in Period

A patient who applies any of the following criteria is not eligible for the study:

Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.
Used systemic steroid within 4 weeks prior to Visit 1.
Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.
Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.
Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.
Has or is suspected to have hypersensitivity to the investigational product, rescue medication or any ingredients of them.
Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study period.
Has received the last dose in another clinical study within 2 months prior to this study.
Is not eligible for the study in the investigator's/subinvestigator's judgment.

Exclusion Criteria for Entry in Treatment Period 1

Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:

Admitted to the hospital due to asthma exacerbation during the run-in period.
Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.
Used prohibited drugs during the 2 weeks just before Visit 2.
Is not eligible for the study in the investigator's/subinvestigator's judgment.

Exclusion Criteria for Entry in Treatment Period 2

Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:

Admitted to the hospital due to asthma exacerbation during the washout period.
Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.
Used prohibited drugs during the 2 weeks just before Visit 4.
Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 51 participants (actual)

Study arms

Active comparator
SLM+FP First
SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).
Drug: GW815SF HFA MDI · Drug: salmeterol and fluticasone propionate
Active comparator
SFC First
SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).
Drug: GW815SF HFA MDI · Drug: salmeterol and fluticasone propionate
Experimental
SFC
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
Drug: GW815SF HFA MDI

Interventions

DrugGW815SF HFA MDI
salmeterol and fluticasone propionate combination
Also known as: salmeterol/fluticasone propionate combination
Drugsalmeterol and fluticasone propionate
salmeterol + fluticasone propionate

What researchers measure

Primary outcomes

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

Secondary outcomes

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
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.
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
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.
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
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.
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
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.
Time frame: Crossover Period Weeks 1-4, 7-10
Percentage of Subjects With Symptom-Free Nights & Days
Percentage of subjects with Symptom Free Nights \& Days after 4 weeks of Treatment
Time frame: Crossover Period Week 1-4, 7-10
Percentage of Subjects With Rescue Medication-Free Nights and Days
Percentage of subjects with Rescue Medication Free Nights \& Days after 4 weeks of Treatment
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
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).
Time frame: Extension Period Weeks 11-30
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
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).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
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).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
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).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
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).
Time frame: Extension Period weeks 11-30
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Symptom Free Nights \& Days after 20 weeks of Treatment (at week 30).
Time frame: Extension Period Weeks 11-30
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Rescue Medication Free Nights \& Days after 20 weeks of Treatment (at week 30).
Time frame: Extension Period Weeks 11-30

Results

Posted Aug 11, 2009

Participant flow

Treatment Period I - 4 Weeks

Participant flow — Treatment Period I - 4 Weeks
Milestone	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
Started	26	25
Completed	26	25
Not completed	0	0

Washout Period - 2 Weeks

Participant flow — Washout Period - 2 Weeks
Milestone	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
Started	26	25
Completed	25	25
Not completed	1	0
Withdrew: Withdrawal by subject	1	0

Treatment Period II - 4 Weeks

Participant flow — Treatment Period II - 4 Weeks
Milestone	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
Started	25	25
Completed	25	25
Not completed	0	0

Extension Period - 20 Weeks

Participant flow — Extension Period - 20 Weeks
Milestone	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
Started	50	0
Completed	50	0
Not completed	0	0

Outcome measures

PrimaryAdjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods

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 \[Weeks 1-4/Weeks 7-10\]).

Time frame:: Crossover Period Weeks 1-4, and 7-10
Reported as:: Mean · Liters/minute

Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Liters/minute	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods	14.3 ± 4.53	17.1 ± 4.53

Statistical analysis

SFC 50/100 Mcg/Day vs SLM 50 Mcg + FP 100 Mcg/Day · Mixed Models Analysis · p = 0.6383 (Confidence Interval) · Mean difference (net): 2.8 · 95% CI -9.10 to 14.69

SecondaryAdjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods

Time frame:: Crossover Period Weeks 1-4, 7-10
Reported as:: Mean · Percentage of predicted value

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Percentage of predicted value	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods	5.38 ± 1.543	6.73 ± 1.543

SecondaryAdjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods

Time frame:: Crossover Period weeks 1-4, 7-10
Reported as:: Mean · Percentage of personal best value

Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Percentage of personal best value	SFC 50/100 Mcg/Day	SLM 50mcg + FP 100 Mcg/Day
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods	5.01 ± 1.480	6.46 ± 1.480

SecondaryAdjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods

Time frame:: Crossover Period weeks 1-4, 7-10
Reported as:: Mean · L/min

Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
L/min	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods	16.3 ± 3.74	15.8 ± 3.74

SecondaryAdjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods

Time frame:: Crossover Period Weeks 1-4, 7-10
Reported as:: Mean · Percentage of circadian variation

Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Percentage of circadian variation	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods	0.06 ± 0.638	-0.08 ± 0.638

SecondaryPercentage of Subjects With Symptom-Free Nights & Days

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

Time frame:: Crossover Period Week 1-4, 7-10
Reported as:: Number · Percent of participants

Percentage of Subjects With Symptom-Free Nights & Days
Percent of participants	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Baseline	72.9	81.3
After 4 Weeks of Treatment	91.7	81.3

SecondaryPercentage of Subjects With Rescue Medication-Free Nights and Days

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

Time frame:: Crossover Period Weeks 1-4, 7-10
Reported as:: Number · Percentage of participants

Percentage of Subjects With Rescue Medication-Free Nights and Days
Percentage of participants	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Baseline	87.5	87.5
After 4 Weeks of Treatment	93.8	87.5

SecondaryAdjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period

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).

Time frame:: Extension Period Weeks 11-30
Reported as:: Mean · L/min

Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
L/min	SFC 50/100 Mcg/Day
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period	3.0 ± 24.56

SecondaryAdjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period

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).

Time frame:: Extension Period weeks 11-30
Reported as:: Mean · Percentage of predicted value

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Percentage of predicted value	SFC 50/100 Mcg/Day
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period	1.46 ± 9.568

SecondaryAdjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period

Time frame:: Extension Period weeks 11-30
Reported as:: Mean · Percentage of personal best value

Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Percentage of personal best value	SFC 50/100 Mcg/Day
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period	1.29 ± 8.541

SecondaryAdjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period

Time frame:: Extension Period weeks 11-30
Reported as:: Mean · L/Min

Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
L/Min	SFC 50/100 Mcg/Day
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period	2.7 ± 23.43

SecondaryAdjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period

Time frame:: Extension Period weeks 11-30
Reported as:: Mean · Percentage of circadian variation

Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Percentage of circadian variation	SFC 50/100 Mcg/Day
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period	-0.37 ± 3.568

SecondaryPercentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment

Percentage of subjects with Symptom Free Nights \& Days after 20 weeks of Treatment (at week 30).

Time frame:: Extension Period Weeks 11-30
Reported as:: Number · Percentage of participants

Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Percentage of participants	SFC 50/100 Mcg/Day
Baseline	84.0
After 20 weeks of treatment (at week 30)	84.8

SecondaryPercentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment

Percentage of subjects with Rescue Medication Free Nights \& Days after 20 weeks of Treatment (at week 30).

Time frame:: Extension Period Weeks 11-30
Reported as:: Number · Percentage of participants

Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Percentage of participants	SFC 50/100 Mcg/Day
Baseline	90.0
After 20 weeks of treatment (at week 30)	89.1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SFC 50/100 Mcg/Day	—	0/51 (0%)	12/51 (23.5%)
SLM 50 + FP 100 Mcg/Day	—	0/50 (0%)	10/50 (20%)
SFC 50/100mcg/Day (Extension Period)	—	0/51 (0%)	35/51 (68.6%)

Most frequent other events

Most frequent other events
Event	SFC 50/100 Mcg/Day	SLM 50 + FP 100 Mcg/Day	SFC 50/100mcg/Day (Extension Period)
Upper Respiratory Tract inflammationRespiratory, thoracic and mediastinal disorders	7/51	3/50	17/50
NasopharyngitisInfections and infestations	2/51	4/50	7/50
GastroenteritisInfections and infestations	1/51	2/50	7/50
AsthmaRespiratory, thoracic and mediastinal disorders	1/51	1/50	5/50
EczemaSkin and subcutaneous tissue disorders	0/51	0/50	4/50
StomatitisGastrointestinal disorders	2/51	0/50	3/50

Baseline characteristics

Age Continuous
Age Continuous(Years)	Overall Study Population
Mean	8.3 ± 2.41

Sex: Female, Male
Sex: Female, Male(Participants)	Overall Study Population
Female	17
Male	34

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall Study Population
Asian-Japanese Heritage	51

Region of Enrollment
Region of Enrollment(participants)	Overall Study Population
Japan	51

Study locations

8 sites

GSK Investigational Site
Chiba, 260-0001, Japan
GSK Investigational Site
Kanagawa, 245-0018, Japan
GSK Investigational Site
Saitama, 360-0018, Japan
GSK Investigational Site
Saitama, 360-0812, Japan
GSK Investigational Site
Tokyo, 154-0002, Japan
GSK Investigational Site
Tokyo, 154-0017, Japan
GSK Investigational Site
Tokyo, 158-0083, Japan
GSK Investigational Site
Tokyo, 158-0097, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00448435
Lead sponsor: GlaxoSmithKline
First posted: Mar 16, 2007
Start date: Apr 2007
Primary completion: Jan 2008
Completion: Jan 2008
Results posted: Aug 11, 2009
Last update: Jun 8, 2010

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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