Trial Outcomes & Findings for Advair HFA For Chronic Obstructive Pulmonary Disease(COPD) (NCT NCT00633217)
NCT ID: NCT00633217
Last Updated: 2016-12-08
Results Overview
The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.
COMPLETED
PHASE4
247 participants
2 hours after administration of blinded study drug; Baseline through Week 12
2016-12-08
Participant Flow
Participant milestones
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
126
|
|
Overall Study
COMPLETED
|
106
|
103
|
|
Overall Study
NOT COMPLETED
|
15
|
23
|
Reasons for withdrawal
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
9
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Investigator Discretion
|
2
|
0
|
|
Overall Study
Withdrew Consent
|
3
|
3
|
Baseline Characteristics
Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)
Baseline characteristics by cohort
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=121 Participants
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=126 Participants
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
n=5 Participants
|
63.4 years
n=7 Participants
|
61.6 years
n=5 Participants
|
|
Gender
Female
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Gender
Male
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
109 participants
n=5 Participants
|
117 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after administration of blinded study drug; Baseline through Week 12Population: Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.
The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.
Outcome measures
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=116 Participants
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=115 Participants
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug
|
155 milliliters (mL)
Standard Error 23.4
|
150 milliliters (mL)
Standard Error 21.9
|
SECONDARY outcome
Timeframe: Measurement of FEV1 prior to study drug administration; Baseline through Week 12Population: ITT Population. The numbers analyzed do not match Baseline numbers due to missing data for some participants.
Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.
Outcome measures
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=116 Participants
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=115 Participants
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Mean Change From Baseline in AM Pre-dose FEV1
|
74 mL
Standard Error 20.6
|
77 mL
Standard Error 20.5
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: ITT Population. Some participants did not have measured values for peak expiratory flow and were thus not included in the analysis.
The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.
Outcome measures
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=119 Participants
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=116 Participants
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Mean Change From Baseline in Peak Expiratory Flow
|
21.8 Liters/minute (L/min)
Standard Error 2.66
|
18.7 Liters/minute (L/min)
Standard Error 2.48
|
Adverse Events
HFA MDI 230/42 mcg and Matching DISKUS Placebo
DISKUS 250/50 mcg and Matching HFA MDI Placebo
Serious adverse events
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=121 participants at risk
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=126 participants at risk
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease Exacerbation
|
2.5%
3/121
|
1.6%
2/126
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
2/121
|
0.00%
0/126
|
|
Infections and infestations
Pneumonia
|
0.00%
0/121
|
0.79%
1/126
|
|
Infections and infestations
Appendicitis
|
0.83%
1/121
|
0.79%
1/126
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
1/121
|
0.00%
0/126
|
|
Injury, poisoning and procedural complications
Contusion
|
0.83%
1/121
|
0.00%
0/126
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.83%
1/121
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.83%
1/121
|
0.00%
0/126
|
Other adverse events
| Measure |
HFA MDI 230/42 mcg and Matching DISKUS Placebo
n=121 participants at risk
Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
|
DISKUS 250/50 mcg and Matching HFA MDI Placebo
n=126 participants at risk
Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
10/121
|
6.3%
8/126
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
5/121
|
6.3%
8/126
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
4/121
|
4.0%
5/126
|
|
Infections and infestations
Sinusitis
|
2.5%
3/121
|
4.8%
6/126
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
5/121
|
1.6%
2/126
|
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