Trial Outcomes & Findings for 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 (NCT NCT00527826)
NCT ID: NCT00527826
Last Updated: 2012-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
214 participants
Primary outcome timeframe
Baseline through Week 52
Results posted on
2012-10-30
Participant Flow
Participant milestones
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
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/FP Separately (Sal/FP) 50/500 µg
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
106
|
|
Overall Study
COMPLETED
|
87
|
80
|
|
Overall Study
NOT COMPLETED
|
21
|
26
|
Reasons for withdrawal
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
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/FP Separately (Sal/FP) 50/500 µg
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Inclusion Criteria Not Met
|
3
|
3
|
|
Overall Study
Alpha-1 Antitrypsin Deficiency
|
0
|
1
|
|
Overall Study
Additional Intake of Viani forte
|
0
|
1
|
|
Overall Study
Participant moved away
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Severity of Chronic Obstructive Lung Disease (COPD)
Severe COPD
|
77 participants
n=5 Participants
|
79 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Severity of Chronic Obstructive Lung Disease (COPD)
Very severe COPD
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Smoking History
Ex-smoker
|
74 participants
n=5 Participants
|
78 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Smoking History
Smoker
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 52Population: Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Number of Exacerbations Per Year: Negative Binomial Model
|
0.864 Number of exacerbations per year
Standard Error 0.134
|
0.862 Number of exacerbations per year
Standard Error 0.138
|
—
|
PRIMARY outcome
Timeframe: Baseline through Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Number of Exacerbations Per Year: Poisson Model
|
0.863 Number of exacerbations per year
Standard Error 0.136
|
0.830 Number of exacerbations per year
Standard Error 0.137
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=105 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Compliance and Adherence to Study Medication
|
97.08 percentage of doses
Standard Deviation 11.61
|
98.44 percentage of doses
Standard Deviation 19.62
|
98.33 percentage of doses
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=98 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=96 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=194 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Number of COPD-related Visits at/by Physician
|
1.39 number of visits
Standard Deviation 2.33
|
1.06 number of visits
Standard Deviation 2.23
|
1.23 number of visits
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: ITT Population of participants who were admitted to the ICU
The number participants with the indicated number of days at the ICU was recorded.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=25 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=16 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=41 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
6-10 days
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
11-30 days
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
>30 days
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
0 days
|
19 participants
|
13 participants
|
32 participants
|
|
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
1-5 days
|
4 participants
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: ITT Population
The number of participants with the indicated number of hospitalizations was recorded.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Number of Participants With the Indicated Number of Hospital Stays
1 hospital stay
|
11 participants
|
13 participants
|
24 participants
|
|
Number of Participants With the Indicated Number of Hospital Stays
2 hospital stays
|
9 participants
|
3 participants
|
12 participants
|
|
Number of Participants With the Indicated Number of Hospital Stays
3 hospital stays
|
4 participants
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Number of Hospital Stays
4 hospital stays
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Number of Hospital Stays
0 hospital stays
|
82 participants
|
87 participants
|
169 participants
|
|
Number of Participants With the Indicated Number of Hospital Stays
5 or more hospital stays
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])Population: ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).
Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=101 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=98 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=199 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Number of Days Rescue Medication Was Used
Visit 2 (Week 8)
|
4.73 number of days
Standard Deviation 2.37
|
4.11 number of days
Standard Deviation 2.77
|
4.43 number of days
Standard Deviation 2.58
|
|
Mean Number of Days Rescue Medication Was Used
Final visit (Week 52)
|
5.03 number of days
Standard Deviation 2.45
|
4.69 number of days
Standard Deviation 2.67
|
4.86 number of days
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Mean change from baseline
|
2.17 percent of predicted value
Standard Deviation 10.42
|
3.08 percent of predicted value
Standard Deviation 12.08
|
2.62 percent of predicted value
Standard Deviation 11.26
|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Baseline
|
36.82 percent of predicted value
Standard Deviation 8.93
|
38.15 percent of predicted value
Standard Deviation 9.26
|
37.47 percent of predicted value
Standard Deviation 9.10
|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Week 52
|
38.98 percent of predicted value
Standard Deviation 13.15
|
41.22 percent of predicted value
Standard Deviation 15.26
|
40.09 percent of predicted value
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52
Baseline
|
2.17 liters
Standard Deviation 0.74
|
2.29 liters
Standard Deviation 0.71
|
2.23 liters
Standard Deviation 0.72
|
|
Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52
Week 52
|
2.14 liters
Standard Deviation 0.72
|
2.27 liters
Standard Deviation 0.68
|
2.21 liters
Standard Deviation 0.70
|
|
Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52
Mean change from baseline
|
-0.02 liters
Standard Deviation 0.53
|
-0.02 liters
Standard Deviation 0.50
|
-0.02 liters
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in the Tiffeaneau Index at Week 52
Baseline
|
48.90 percent of IVC
Standard Deviation 11.09
|
49.05 percent of IVC
Standard Deviation 10.76
|
48.98 percent of IVC
Standard Deviation 10.90
|
|
Mean Change From Baseline in the Tiffeaneau Index at Week 52
Week 52
|
50.82 percent of IVC
Standard Deviation 10.98
|
52.83 percent of IVC
Standard Deviation 16.39
|
51.81 percent of IVC
Standard Deviation 13.93
|
|
Mean Change From Baseline in the Tiffeaneau Index at Week 52
Mean change from baseline
|
1.92 percent of IVC
Standard Deviation 8.76
|
3.78 percent of IVC
Standard Deviation 13.42
|
2.84 percent of IVC
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Baseline
|
68.80 percent
Standard Deviation 19.65
|
68.95 percent
Standard Deviation 18.38
|
68.88 percent
Standard Deviation 18.99
|
|
Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Mean change from baseline
|
-3.38 percent
Standard Deviation 17.65
|
-5.18 percent
Standard Deviation 17.27
|
-4.27 percent
Standard Deviation 17.44
|
|
Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Week 52
|
65.42 percent
Standard Deviation 19.76
|
63.77 percent
Standard Deviation 19.94
|
64.61 percent
Standard Deviation 19.82
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Baseline
|
72.80 percent
Standard Deviation 17.78
|
70.64 percent
Standard Deviation 17.45
|
71.73 percent
Standard Deviation 17.61
|
|
Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Week 52
|
71.17 percent
Standard Deviation 20.29
|
68.53 percent
Standard Deviation 21.72
|
69.86 percent
Standard Deviation 21.01
|
|
Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Mean change from baseline
|
-1.63 percent
Standard Deviation 16.63
|
-2.11 percent
Standard Deviation 16.53
|
-1.87 percent
Standard Deviation 16.54
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=112 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Mean change from baseline
|
-1.37 percent
Standard Deviation 17.52
|
-2.32 percent
Standard Deviation 17.87
|
-1.84 percent
Standard Deviation 17.66
|
|
Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Baseline
|
46.03 percent
Standard Deviation 20.30
|
43.58 percent
Standard Deviation 17.37
|
44.82 percent
Standard Deviation 18.90
|
|
Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Week 52
|
44.66 percent
Standard Deviation 21.15
|
41.26 percent
Standard Deviation 19.53
|
42.98 percent
Standard Deviation 20.39
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Week 52
|
56.02 percent
Standard Deviation 18.22
|
53.25 percent
Standard Deviation 17.71
|
54.65 percent
Standard Deviation 17.98
|
|
Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Mean change from baseline
|
-1.80 percent
Standard Deviation 14.42
|
-2.64 percent
Standard Deviation 14.73
|
-2.22 percent
Standard Deviation 14.55
|
|
Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Baseline
|
57.82 percent
Standard Deviation 17.07
|
55.89 percent
Standard Deviation 15.36
|
56.87 percent
Standard Deviation 16.24
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=107 Participants
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/FP Separately (Sal/FP) 50/500 µg
n=105 Participants
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
FP 500 µg
n=212 Participants
Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
|
|---|---|---|---|
|
Mean Total Costs (Related to COPD) Per Participant
|
1453 Euros per participant
Standard Deviation 2427
|
1166 Euros per participant
Standard Deviation 1534
|
1311 Euros per participant
Standard Deviation 2034
|
Adverse Events
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
Serious events: 23 serious events
Other events: 45 other events
Deaths: 0 deaths
Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=108 participants at risk
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/FP Separately (Sal/FP) 50/500 µg
n=105 participants at risk
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Cardiac disorders
Cardiac failure
|
0.93%
1/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Cardiac disorders
Tachyarrhythmia
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Duodenitis
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Gastrointestinal disorders
Gastritis
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
General disorders
Chest pain
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
General disorders
Pain
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.9%
2/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Infections and infestations
Pneumonia
|
2.8%
3/108 • 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).
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).
|
3.8%
4/105 • 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).
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).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.93%
1/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Nervous system disorders
Syncope
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
11.1%
12/108 • 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).
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).
|
6.7%
7/105 • 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).
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Surgical and medical procedures
Cardioplegia
|
0.00%
0/108 • 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).
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).
|
0.95%
1/105 • 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).
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).
|
|
Vascular disorders
Arterial occlusive disease
|
0.93%
1/108 • 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).
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).
|
0.00%
0/105 • 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).
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).
|
Other adverse events
| Measure |
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg
n=108 participants at risk
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/FP Separately (Sal/FP) 50/500 µg
n=105 participants at risk
Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
30.6%
33/108 • 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).
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).
|
31.4%
33/105 • 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).
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
4/108 • 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).
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).
|
5.7%
6/105 • 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).
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).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
11.1%
12/108 • 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).
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).
|
15.2%
16/105 • 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).
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).
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/108 • 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).
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).
|
7.6%
8/105 • 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).
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).
|
|
Infections and infestations
Pneumonia
|
6.5%
7/108 • 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).
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).
|
4.8%
5/105 • 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).
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).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER