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Trial record 33 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT00448435
Recruitment Status : Completed
First Posted : March 16, 2007
Results First Posted : August 11, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bronchial Asthma
Interventions Drug: GW815SF HFA MDI
Drug: salmeterol and fluticasone propionate
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SFC 50/100 Mcg/Day First SLM 50 Mcg + FP 100 Mcg/Day First
Hide Arm/Group 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). 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).
Period Title: Treatment Period I - 4 Weeks
Started 26 25
Completed 26 25
Not Completed 0 0
Period Title: Washout Period - 2 Weeks
Started 26 25
Completed 25 25
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Treatment Period II - 4 Weeks
Started 25 25
Completed 25 25
Not Completed 0 0
Period Title: Extension Period - 20 Weeks
Started 50 0
Completed 50 0
Not Completed 0 0
Arm/Group Title Overall Study Population
Hide Arm/Group Description Randomized Population
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
8.3  (2.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
17
  33.3%
Male
34
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian-Japanese Heritage Number Analyzed 51 participants
51
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 51 participants
51
1.Primary Outcome
Title Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: Liters/minute
14.3  (4.53) 17.1  (4.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SFC 50/100 Mcg/Day, SLM 50 Mcg + FP 100 Mcg/Day
Comments Difference between treatments [(SLM + FP)- SFC](SE) 2.8 (5.91)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence margin + or - 15 L/min
Statistical Test of Hypothesis P-Value 0.6383
Comments Confidence Interval
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.8
Confidence Interval 95%
-9.10 to 14.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.91
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: Percentage of predicted value
5.38  (1.543) 6.73  (1.543)
3.Secondary Outcome
Title Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: Percentage of personal best value
5.01  (1.480) 6.46  (1.480)
4.Secondary Outcome
Title Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: L/min
16.3  (3.74) 15.8  (3.74)
5.Secondary Outcome
Title Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: Percentage of circadian variation
0.06  (0.638) -0.08  (0.638)
6.Secondary Outcome
Title Percentage of Subjects With Symptom-Free Nights & Days
Hide Description Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment
Time Frame Crossover Period Week 1-4, 7-10
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Percent of participants
Baseline 72.9 81.3
After 4 Weeks of Treatment 91.7 81.3
7.Secondary Outcome
Title Percentage of Subjects With Rescue Medication-Free Nights and Days
Hide Description Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment
Time Frame Crossover Period Weeks 1-4, 7-10
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 Mcg + FP 100 Mcg/Day
Hide Arm/Group Description:
Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 87.5 87.5
After 4 Weeks of Treatment 93.8 87.5
8.Secondary Outcome
Title Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: L/min
3.0  (24.56)
9.Secondary Outcome
Title Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percentage of predicted value
1.46  (9.568)
10.Secondary Outcome
Title Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percentage of personal best value
1.29  (8.541)
11.Secondary Outcome
Title Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: L/Min
2.7  (23.43)
12.Secondary Outcome
Title Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percentage of circadian variation
-0.37  (3.568)
13.Secondary Outcome
Title Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Hide Description Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame Extension Period Weeks 11-30
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 84.0
After 20 weeks of treatment (at week 30) 84.8
14.Secondary Outcome
Title Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.
Arm/Group Title SFC 50/100 Mcg/Day
Hide Arm/Group Description:
Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 90.0
After 20 weeks of treatment (at week 30) 89.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SFC 50/100 Mcg/Day SLM 50 + FP 100 Mcg/Day SFC 50/100mcg/Day (Extension Period)
Hide Arm/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 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 Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
All-Cause Mortality
SFC 50/100 Mcg/Day SLM 50 + FP 100 Mcg/Day SFC 50/100mcg/Day (Extension Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SFC 50/100 Mcg/Day SLM 50 + FP 100 Mcg/Day SFC 50/100mcg/Day (Extension Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/50 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SFC 50/100 Mcg/Day SLM 50 + FP 100 Mcg/Day SFC 50/100mcg/Day (Extension Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/51 (23.53%)   10/50 (20.00%)   35/51 (68.63%) 
Gastrointestinal disorders       
Stomatitis  1  2/51 (3.92%)  0/50 (0.00%)  3/50 (6.00%) 
Infections and infestations       
Nasopharyngitis  2  2/51 (3.92%)  4/50 (8.00%)  7/50 (14.00%) 
Gastroenteritis  1  1/51 (1.96%)  2/50 (4.00%)  7/50 (14.00%) 
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Tract inflammation  1  7/51 (13.73%)  3/50 (6.00%)  17/50 (34.00%) 
Asthma  1  1/51 (1.96%)  1/50 (2.00%)  5/50 (10.00%) 
Skin and subcutaneous tissue disorders       
Eczema  1  0/51 (0.00%)  0/50 (0.00%)  4/50 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
2
Term from vocabulary, MedDRA 10.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00448435     History of Changes
Other Study ID Numbers: 110099
First Submitted: March 14, 2007
First Posted: March 16, 2007
Results First Submitted: January 19, 2009
Results First Posted: August 11, 2009
Last Update Posted: June 8, 2010