Back to resultsClinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Primary Purpose
Bronchial Asthma
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GW815SF HFA MDI
salmeterol and fluticasone propionate
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Salmeterol, Fluticasone propionate, Salmeterol/Fluticasone propionate combination, Pediatric bronchial asthma
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
SLM+FP First
SFC First
SFC
Arm Description
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).
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).
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
Outcomes
Primary Outcome Measures
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]).
Secondary Outcome Measures
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.
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.
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.
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.
Percentage of Subjects With Symptom-Free Nights & Days
Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment
Percentage of Subjects With Rescue Medication-Free Nights and Days
Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment
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).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00448435
Brief Title
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Salmeterol, Fluticasone propionate, Salmeterol/Fluticasone propionate combination, Pediatric bronchial asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLM+FP First
Arm Type
Active Comparator
Arm Description
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).
Arm Title
SFC First
Arm Type
Active Comparator
Arm Description
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).
Arm Title
SFC
Arm Type
Experimental
Arm Description
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
Intervention Type
Drug
Intervention Name(s)
GW815SF HFA MDI
Other Intervention Name(s)
salmeterol/fluticasone propionate combination
Intervention Description
salmeterol and fluticasone propionate combination
Intervention Type
Drug
Intervention Name(s)
salmeterol and fluticasone propionate
Intervention Description
salmeterol + fluticasone propionate
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
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]).
Time Frame
Crossover Period Weeks 1-4, and 7-10
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
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.
Time Frame
Crossover Period Weeks 1-4, 7-10
Title
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
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.
Time Frame
Crossover Period weeks 1-4, 7-10
Title
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
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.
Time Frame
Crossover Period weeks 1-4, 7-10
Title
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
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.
Time Frame
Crossover Period Weeks 1-4, 7-10
Title
Percentage of Subjects With Symptom-Free Nights & Days
Description
Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment
Time Frame
Crossover Period Week 1-4, 7-10
Title
Percentage of Subjects With Rescue Medication-Free Nights and Days
Description
Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment
Time Frame
Crossover Period Weeks 1-4, 7-10
Title
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
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).
Time Frame
Extension Period Weeks 11-30
Title
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
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).
Time Frame
Extension Period weeks 11-30
Title
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
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).
Time Frame
Extension Period weeks 11-30
Title
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
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).
Time Frame
Extension Period weeks 11-30
Title
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
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).
Time Frame
Extension Period weeks 11-30
Title
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Description
Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame
Extension Period Weeks 11-30
Title
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Description
Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame
Extension Period Weeks 11-30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
260-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
245-0018
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
360-0018
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
360-0812
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
154-0002
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
154-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
158-0083
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
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