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Trial record 75 of 318 for:    FLUTICASONE AND SALMETEROL

Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV

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ClinicalTrials.gov Identifier: NCT00527826
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : June 24, 2010
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination
Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Hide Arm/Group Description Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus) Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Period Title: Overall Study
Started 108 [1] 106
Completed 87 80
Not Completed 21 26
Reason Not Completed
Adverse Event             10             10
Lost to Follow-up             3             2
Withdrawal by Subject             5             8
Inclusion Criteria Not Met             3             3
Alpha-1 Antitrypsin Deficiency             0             1
Additional Intake of Viani forte             0             1
Participant moved away             0             1
[1]
All Patients Population was used for Participant Flow section.
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus) Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus) Total of all reporting groups
Overall Number of Baseline Participants 107 105 212
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 105 participants 212 participants
65.6  (8.3) 64.2  (8.9) 64.9  (8.6)
[1]
Measure Description: Age at study start (years). The Intent-to-Treat (ITT) Population (all participants receiving at least one dose of study medication and suffering from COPD) was used for all baseline characteristics.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 105 participants 212 participants
Female
33
  30.8%
29
  27.6%
62
  29.2%
Male
74
  69.2%
76
  72.4%
150
  70.8%
[1]
Measure Description: The ITT Population was used.
Severity of Chronic Obstructive Lung Disease (COPD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 105 participants 212 participants
Severe COPD 77 79 156
Very severe COPD 30 26 56
[1]
Measure Description: Severe COPD (stage III) is defined by the global initiative for chronic obstructive lung disease (GOLD) as baseline forced expiratory volume in one second (FEV1) >30% and <50% predicted and FEV1/inspiratory vital capacity (IVC) ratio <70%. Very severe COPD (stage IV) is defined as baseline FEV1 <30% predicted and FEV1/IVC <70%. ITT Population.
Smoking History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 105 participants 212 participants
Ex-smoker 74 78 152
Smoker 33 27 60
[1]
Measure Description: The number of smokers/ex-smokers participating in the study was recorded. The ITT Population was used.
1.Primary Outcome
Title Mean Number of Exacerbations Per Year: Negative Binomial Model
Hide Description During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Overall Number of Participants Analyzed 107 105
Least Squares Mean (Standard Error)
Unit of Measure: Number of exacerbations per year
0.864  (0.134) 0.862  (0.138)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg, Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Negative binomial model
Comments Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.
2.Primary Outcome
Title Mean Number of Exacerbations Per Year: Poisson Model
Hide Description During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Overall Number of Participants Analyzed 107 105
Least Squares Mean (Standard Error)
Unit of Measure: Number of exacerbations per year
0.863  (0.136) 0.830  (0.137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg, Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Poisson model
Comments Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.
3.Secondary Outcome
Title Compliance and Adherence to Study Medication
Hide Description Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Sal 50 µg FP 500 µg
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
Overall Number of Participants Analyzed 107 105 105
Mean (Standard Deviation)
Unit of Measure: percentage of doses
97.08  (11.61) 98.44  (19.62) 98.33  (19.36)
4.Secondary Outcome
Title Mean Number of COPD-related Visits at/by Physician
Hide Description The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 98 96 194
Mean (Standard Deviation)
Unit of Measure: number of visits
1.39  (2.33) 1.06  (2.23) 1.23  (2.28)
5.Secondary Outcome
Title Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
Hide Description The number participants with the indicated number of days at the ICU was recorded.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population of participants who were admitted to the ICU
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 25 16 41
Measure Type: Number
Unit of Measure: participants
0 days 19 13 32
1-5 days 4 2 6
6-10 days 1 1 2
11-30 days 0 0 0
>30 days 1 0 1
6.Secondary Outcome
Title Number of Participants With the Indicated Number of Hospital Stays
Hide Description The number of participants with the indicated number of hospitalizations was recorded.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Measure Type: Number
Unit of Measure: participants
0 hospital stays 82 87 169
1 hospital stay 11 13 24
2 hospital stays 9 3 12
3 hospital stays 4 1 5
4 hospital stays 0 1 1
5 or more hospital stays 1 0 1
7.Secondary Outcome
Title Mean Number of Days Rescue Medication Was Used
Hide Description Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.
Time Frame The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 101 98 199
Mean (Standard Deviation)
Unit of Measure: number of days
Visit 2 (Week 8) 4.73  (2.37) 4.11  (2.77) 4.43  (2.58)
Final visit (Week 52) 5.03  (2.45) 4.69  (2.67) 4.86  (2.56)
8.Secondary Outcome
Title Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Hide Description Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: percent of predicted value
Baseline 36.82  (8.93) 38.15  (9.26) 37.47  (9.10)
Week 52 38.98  (13.15) 41.22  (15.26) 40.09  (14.24)
Mean change from baseline 2.17  (10.42) 3.08  (12.08) 2.62  (11.26)
9.Secondary Outcome
Title Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52
Hide Description Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: liters
Baseline 2.17  (0.74) 2.29  (0.71) 2.23  (0.72)
Week 52 2.14  (0.72) 2.27  (0.68) 2.21  (0.70)
Mean change from baseline -0.02  (0.53) -0.02  (0.50) -0.02  (0.51)
10.Secondary Outcome
Title Mean Change From Baseline in the Tiffeaneau Index at Week 52
Hide Description The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: percent of IVC
Baseline 48.90  (11.09) 49.05  (10.76) 48.98  (10.90)
Week 52 50.82  (10.98) 52.83  (16.39) 51.81  (13.93)
Mean change from baseline 1.92  (8.76) 3.78  (13.42) 2.84  (11.32)
11.Secondary Outcome
Title Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Hide Description Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 68.80  (19.65) 68.95  (18.38) 68.88  (18.99)
Week 52 65.42  (19.76) 63.77  (19.94) 64.61  (19.82)
Mean change from baseline -3.38  (17.65) -5.18  (17.27) -4.27  (17.44)
12.Secondary Outcome
Title Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Hide Description Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 72.80  (17.78) 70.64  (17.45) 71.73  (17.61)
Week 52 71.17  (20.29) 68.53  (21.72) 69.86  (21.01)
Mean change from baseline -1.63  (16.63) -2.11  (16.53) -1.87  (16.54)
13.Secondary Outcome
Title Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Hide Description Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 112
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 46.03  (20.30) 43.58  (17.37) 44.82  (18.90)
Week 52 44.66  (21.15) 41.26  (19.53) 42.98  (20.39)
Mean change from baseline -1.37  (17.52) -2.32  (17.87) -1.84  (17.66)
14.Secondary Outcome
Title Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Hide Description Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: percent
Baseline 57.82  (17.07) 55.89  (15.36) 56.87  (16.24)
Week 52 56.02  (18.22) 53.25  (17.71) 54.65  (17.98)
Mean change from baseline -1.80  (14.42) -2.64  (14.73) -2.22  (14.55)
15.Secondary Outcome
Title Mean Total Costs (Related to COPD) Per Participant
Hide Description Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used "as required" were assumed to be used every second day.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Total
Hide Arm/Group Description:
Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total number of participants randomized to the SFC and Sal/FP groups
Overall Number of Participants Analyzed 107 105 212
Mean (Standard Deviation)
Unit of Measure: Euros per participant
1453  (2427) 1166  (1534) 1311  (2034)
Time Frame Adverse events (AE) and serious adverse events (SAEs) were collected after the start of the study (visit 1, Week 0) until the last visit (visit 6, Week 52).
Adverse Event Reporting Description The Safety Population (all participants who took at least one dose of study medication) was used for the analysis of SAEs/AEs. One participant in the Sal/FP group was excluded from the safety population because (s)he took no study medication (returned the study medication unused).
 
Arm/Group Title Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Hide Arm/Group Description Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus) Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
All-Cause Mortality
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   23/108 (21.30%)   16/105 (15.24%) 
Blood and lymphatic system disorders     
Anaemia  1  1/108 (0.93%)  0/105 (0.00%) 
Cardiac disorders     
Arrhythmia  1  0/108 (0.00%)  1/105 (0.95%) 
Atrial fibrillation  1  0/108 (0.00%)  1/105 (0.95%) 
Cardiac failure  1  1/108 (0.93%)  1/105 (0.95%) 
Cyanosis  1  0/108 (0.00%)  1/105 (0.95%) 
Tachyarrhythmia  1  1/108 (0.93%)  0/105 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/108 (0.93%)  0/105 (0.00%) 
Duodenal stenosis  1  1/108 (0.93%)  0/105 (0.00%) 
Duodenitis  1  1/108 (0.93%)  0/105 (0.00%) 
Gastric ulcer  1  0/108 (0.00%)  1/105 (0.95%) 
Gastritis  1  1/108 (0.93%)  0/105 (0.00%) 
Gastrointestinal haemorrhage  1  0/108 (0.00%)  1/105 (0.95%) 
Haemorrhoids  1  1/108 (0.93%)  0/105 (0.00%) 
Intestinal haemorrhage  1  0/108 (0.00%)  1/105 (0.95%) 
General disorders     
Chest pain  1  1/108 (0.93%)  0/105 (0.00%) 
Pain  1  0/108 (0.00%)  1/105 (0.95%) 
Infections and infestations     
Infective exacerbation of chronic obstructive airways disease  1  2/108 (1.85%)  1/105 (0.95%) 
Pneumonia  1  3/108 (2.78%)  4/105 (3.81%) 
Injury, poisoning and procedural complications     
Concussion  1  1/108 (0.93%)  0/105 (0.00%) 
Rib fracture  1  1/108 (0.93%)  0/105 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/108 (0.93%)  0/105 (0.00%) 
Intervertebral disc protrusion  1  1/108 (0.93%)  1/105 (0.95%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/108 (0.93%)  0/105 (0.00%) 
Bladder neoplasm  1  0/108 (0.00%)  1/105 (0.95%) 
Breast cancer  1  1/108 (0.93%)  0/105 (0.00%) 
Bronchial carcinoma  1  1/108 (0.93%)  0/105 (0.00%) 
Laryngeal cancer  1  1/108 (0.93%)  0/105 (0.00%) 
Nervous system disorders     
Cervicobrachial syndrome  1  1/108 (0.93%)  0/105 (0.00%) 
Syncope  1  1/108 (0.93%)  0/105 (0.00%) 
Transient ischaemic attack  1  1/108 (0.93%)  0/105 (0.00%) 
Renal and urinary disorders     
Renal failure  1  0/108 (0.00%)  1/105 (0.95%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/108 (0.93%)  0/105 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/108 (0.00%)  1/105 (0.95%) 
Chronic obstructive pulmonary disease  1  12/108 (11.11%)  7/105 (6.67%) 
Dyspnoea  1  0/108 (0.00%)  1/105 (0.95%) 
Pulmonary embolism  1  0/108 (0.00%)  1/105 (0.95%) 
Surgical and medical procedures     
Cardioplegia  1  0/108 (0.00%)  1/105 (0.95%) 
Vascular disorders     
Arterial occlusive disease  1  1/108 (0.93%)  0/105 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   45/108 (41.67%)   48/105 (45.71%) 
Infections and infestations     
Infective exacerbation of chronic obstructive airways disease  1  12/108 (11.11%)  16/105 (15.24%) 
Nasopharyngitis  1  3/108 (2.78%)  8/105 (7.62%) 
Pneumonia  1  7/108 (6.48%)  5/105 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  33/108 (30.56%)  33/105 (31.43%) 
Dyspnoea  1  4/108 (3.70%)  6/105 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00527826     History of Changes
Other Study ID Numbers: SCO107227
First Submitted: September 10, 2007
First Posted: September 11, 2007
Results First Submitted: March 10, 2010
Results First Posted: June 24, 2010
Last Update Posted: October 30, 2012