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Trial record 90 of 318 for:    FLUTICASONE AND SALMETEROL

Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

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ClinicalTrials.gov Identifier: NCT00353873
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : April 24, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Fluticasone propionate
Drug: Fluticasone propionate/salmeterol
Enrollment 506
Recruitment Details The study was conducted at 46 sites in 12 countries: Belgium (4), Denmark (1), France (8), Italy (3), Latvia (3), Lithuania (3), the Netherlands (6), Norway (1), Poland (4), Russian Federation (9), Spain (3) and Sweden (1) from 18 November 2005 to 26 October 2006.
Pre-assignment Details A total of 584 participants were screened and entered into a 4-week run-in period receiving fluticasone propionate (FP) 100 microgram (mcg) dry powder inhaler (DISKUS) twice-daily (BD) and inhaled salbutamol as required. The number of participants randomized was 321 and 303 participants received investigational product post randomization.
Arm/Group Title FP 200 mcg BD Salmeterol/Fluticasone Propionate (SFC) 50/100 mcg BD
Hide Arm/Group Description Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms. Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Period Title: Overall Study
Started 153 150
Completed 147 147
Not Completed 6 3
Reason Not Completed
Protocol Violation             1             2
Exacerbation             1             0
Adverse Event             1             0
Physician Decision             2             0
Withdrawal by Subject             1             1
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD Total
Hide Arm/Group Description Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms. Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms. Total of all reporting groups
Overall Number of Baseline Participants 153 150 303
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 150 participants 303 participants
8.0  (2.01) 8.1  (2.00) 8.0  (2.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 150 participants 303 participants
Female
55
  35.9%
53
  35.3%
108
  35.6%
Male
98
  64.1%
97
  64.7%
195
  64.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 150 participants 303 participants
African American/African Heritage 3 2 5
White - Arabic/North African Heritage 4 4 8
White - White/Caucasian/European Heritage 146 144 290
1.Primary Outcome
Title Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population
Hide Description PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.
Time Frame Baseline; Week 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: All participants randomized to treatment who received at least one dose of randomized study medication. Only participants with analyzable data at the indicated time point were assessed.
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD
Hide Arm/Group Description:
Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Overall Number of Participants Analyzed 152 150
Least Squares Mean (Standard Error)
Unit of Measure: Liters/Minute (L/min)
19.3  (2.12) 26.9  (2.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FP 200 mcg BD, SFC 50/100 mcg BD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
1.7 to 13.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.01
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population
Hide Description PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.
Time Frame Baseline; Week 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population: All participants in the ITT Population who did not have any protocol violations which could impact treatment effect. Only participants with analyzable data at the indicated time point were assessed.
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD
Hide Arm/Group Description:
Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Overall Number of Participants Analyzed 135 127
Least Squares Mean (Standard Error)
Unit of Measure: L/min
18.4  (2.14) 27.7  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FP 200 mcg BD, SFC 50/100 mcg BD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
3.2 to 15.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma
Hide Description TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as ‘TC’, ‘Well Controlled’ (WC), ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.
Time Frame Week 5 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with analyzable data at the indicated time point were assessed.
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD
Hide Arm/Group Description:
Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Overall Number of Participants Analyzed 152 150
Measure Type: Number
Unit of Measure: Participants
23 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FP 200 mcg BD, SFC 50/100 mcg BD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.7 to 2.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Achieved WC Asthma
Hide Description WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as ‘WC’, ‘Not Controlled’ or ‘Unevaluable’. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. ‘Unevaluable’ classification included participants with less than 4 wks of data during the assessment period.
Time Frame Week 5 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with analyzable data at the indicated time point were assessed.
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD
Hide Arm/Group Description:
Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
Overall Number of Participants Analyzed 152 150
Measure Type: Number
Unit of Measure: Participants
61 65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FP 200 mcg BD, SFC 50/100 mcg BD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.7 to 1.9
Estimation Comments [Not Specified]
Time Frame Serious adverse events and non-serious adverse events were collected from the first day of treatment until the last day of treatment (up to 12 weeks).
Adverse Event Reporting Description On-treatment serious adverse events and non-serious adverse events were reported for ITT Population.
 
Arm/Group Title FP 200 mcg BD SFC 50/100 mcg BD
Hide Arm/Group Description Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms. Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
All-Cause Mortality
FP 200 mcg BD SFC 50/100 mcg BD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FP 200 mcg BD SFC 50/100 mcg BD
Affected / at Risk (%) Affected / at Risk (%)
Total   3/153 (1.96%)   3/150 (2.00%) 
Gastrointestinal disorders     
Gastritis  1  1/153 (0.65%)  0/150 (0.00%) 
Infections and infestations     
Laryngotracheitis  1  0/153 (0.00%)  1/150 (0.67%) 
Wound infection  1  1/153 (0.65%)  0/150 (0.00%) 
Injury, poisoning and procedural complications     
Concussion  1  0/153 (0.00%)  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/153 (0.65%)  1/150 (0.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FP 200 mcg BD SFC 50/100 mcg BD
Affected / at Risk (%) Affected / at Risk (%)
Total   61/153 (39.87%)   55/150 (36.67%) 
Gastrointestinal disorders     
Abdominal pain  1  6/153 (3.92%)  8/150 (5.33%) 
Infections and infestations     
Nasopharyngitis  1  19/153 (12.42%)  14/150 (9.33%) 
Rhinitis  1  10/153 (6.54%)  12/150 (8.00%) 
Nervous system disorders     
Headache  1  23/153 (15.03%)  27/150 (18.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/153 (6.54%)  7/150 (4.67%) 
Rhinitis allergic  1  10/153 (6.54%)  6/150 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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 any 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 precede 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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00353873     History of Changes
Other Study ID Numbers: SAM104926
First Submitted: July 18, 2006
First Posted: July 19, 2006
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: May 28, 2018