Trial Outcomes & Findings for A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma (NCT NCT00452348)
NCT ID: NCT00452348
Last Updated: 2016-12-09
Results Overview
Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
COMPLETED
PHASE4
628 participants
Baseline and Week 1 through Week 52
2016-12-09
Participant Flow
Participant milestones
| Measure |
FSC DISKUS 250/50 mcg BID
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
310
|
318
|
|
Overall Study
COMPLETED
|
231
|
234
|
|
Overall Study
NOT COMPLETED
|
79
|
84
|
Reasons for withdrawal
| Measure |
FSC DISKUS 250/50 mcg BID
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
9
|
|
Overall Study
Lack of Efficacy
|
10
|
9
|
|
Overall Study
Lost to Follow-up
|
14
|
8
|
|
Overall Study
Protocol Violation
|
22
|
28
|
|
Overall Study
Withdrawal by Subject
|
18
|
21
|
|
Overall Study
Other
|
9
|
9
|
Baseline Characteristics
A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma
Baseline characteristics by cohort
| Measure |
FSC DISKUS 250/50 mcg BID
n=310 Participants
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=318 Participants
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 15.71 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 16.56 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 16.15 • n=5 Participants
|
|
Gender
Female
|
186 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Gender
Male
|
124 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
254 participants
n=5 Participants
|
262 participants
n=7 Participants
|
516 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 1 through Week 52Population: Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1
Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
Outcome measures
| Measure |
FSC DISKUS 250/50 mcg BID
n=303 Participants
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=304 Participants
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52
|
0.16 Liters
Standard Error 0.017
|
0.12 Liters
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline and Week 1 through Week 52Population: Participants in the ITT Population who had a minimum of 1 week PEF values
Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
Outcome measures
| Measure |
FSC DISKUS 250/50 mcg BID
n=305 Participants
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=310 Participants
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Mean Change From Baseline in AM PEF Over Weeks 1-52
|
27.7 Liters/minute (L/min)
Standard Error 2.85
|
14.6 Liters/minute (L/min)
Standard Error 2.49
|
SECONDARY outcome
Timeframe: Baseline and Week 1 through Week 52Population: Participants in the ITT Population for which at least 1 week of diary data were provided
A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.
Outcome measures
| Measure |
FSC DISKUS 250/50 mcg BID
n=305 Participants
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=310 Participants
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52
|
37.4 Percentage of symptom-free days
Standard Error 2.03
|
28.9 Percentage of symptom-free days
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Week 1 through Week 52Population: ITT Population
The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a \>=20% decrease in AM PEF, a \>=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.
Outcome measures
| Measure |
FSC DISKUS 250/50 mcg BID
n=310 Participants
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=318 Participants
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Rate of Asthma Attacks Per Participant Per Year
|
2.63 attacks per participant per year
Interval 2.17 to 3.19
|
2.73 attacks per participant per year
Interval 2.26 to 3.31
|
Adverse Events
FSC DISKUS 250/50 mcg BID
FP DISKUS 250 mcg BID for 52 Weeks
Serious adverse events
| Measure |
FSC DISKUS 250/50 mcg BID
n=310 participants at risk
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=318 participants at risk
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
General disorders
Cardiac death
|
0.32%
1/310
|
0.00%
0/318
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/310
|
0.31%
1/318
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/310
|
0.63%
2/318
|
|
Infections and infestations
Cholecystitis
|
0.00%
0/310
|
0.31%
1/318
|
|
Infections and infestations
Appendicitis
|
0.00%
0/310
|
0.31%
1/318
|
|
Infections and infestations
Cellulitis
|
0.00%
0/310
|
0.31%
1/318
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.32%
1/310
|
0.00%
0/318
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/310
|
0.31%
1/318
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/310
|
0.31%
1/318
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/310
|
0.31%
1/318
|
|
Reproductive system and breast disorders
Breast cancer
|
0.32%
1/310
|
0.31%
1/318
|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/310
|
0.00%
0/318
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/310
|
0.00%
0/318
|
|
Nervous system disorders
Syncope
|
0.00%
0/310
|
0.31%
1/318
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/310
|
0.31%
1/318
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.32%
1/310
|
0.00%
0/318
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/310
|
0.00%
0/318
|
|
General disorders
Chest pain
|
0.00%
0/310
|
0.31%
1/318
|
Other adverse events
| Measure |
FSC DISKUS 250/50 mcg BID
n=310 participants at risk
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
|
FP DISKUS 250 mcg BID for 52 Weeks
n=318 participants at risk
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.5%
45/310
|
17.3%
55/318
|
|
Infections and infestations
Nasopharyngitis
|
17.4%
54/310
|
22.0%
70/318
|
|
Infections and infestations
Bronchitis
|
11.0%
34/310
|
11.9%
38/318
|
|
Infections and infestations
Influenza
|
4.8%
15/310
|
6.6%
21/318
|
|
Infections and infestations
Sinusitis
|
10.6%
33/310
|
12.6%
40/318
|
|
Nervous system disorders
Headache
|
16.5%
51/310
|
18.9%
60/318
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
19/310
|
5.7%
18/318
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
23/310
|
6.0%
19/318
|
|
Infections and infestations
Rhinitis
|
7.4%
23/310
|
5.7%
18/318
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
23/310
|
7.5%
24/318
|
Additional Information
GSK Response Center
GlaxoSmithKline
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