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Trial record 60 of 318 for:    FLUTICASONE AND SALMETEROL

A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01706328
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : March 5, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/VI 100/25 Inhalation Powder NDPI
Drug: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS
Drug: Placebo Inhalation Powder NDPI
Drug: Placebo Inhalation Powder ACCUHALER/DISKUS
Drug: Salbutamol as needed
Enrollment 828
Recruitment Details Only those participants that started the Double-blind Treatment Period were considered enrolled.
Pre-assignment Details At Visit 1, participants entered a 2-week, single-blind (placebo) Run-in Period to obtain Baseline assessments of salbutamol use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week, double-blind Treatment Period.
Arm/Group Title Placebo + Salbutamol FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Hide Arm/Group Description Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit. Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study. Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
Period Title: 2-week Run-in Period
Started 993 0 0
Completed 828 0 0
Not Completed 165 0 0
Reason Not Completed
Inclusion/Exclusion Criteria Not Met             140             0             0
Withdrawal by Subject             15             0             0
Physician Decision             4             0             0
Adverse Event             4             0             0
Lost to Follow-up             2             0             0
Period Title: 12-week Double-blind Treatment Period
Started 0 412 416
Completed 0 366 371
Not Completed 0 46 45
Reason Not Completed
Adverse Event             0             14             16
Lack of Efficacy             0             4             4
Protocol Violation             0             4             2
Protocol-defined Stopping Criteria Met             0             11             9
Lost to Follow-up             0             3             1
Physician Decision             0             2             2
Withdrawal by Subject             0             8             11
Arm/Group Title FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID Total
Hide Arm/Group Description Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study. Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 412 416 828
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 412 participants 416 participants 828 participants
61.0  (8.17) 61.3  (8.37) 61.1  (8.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 412 participants 416 participants 828 participants
Female
111
  26.9%
122
  29.3%
233
  28.1%
Male
301
  73.1%
294
  70.7%
595
  71.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 412 participants 416 participants 828 participants
African American/African Heritage 9 5 14
American Indian or Alaska Native 0 1 1
White-White/Caucasian/European Heritage 403 410 813
1.Primary Outcome
Title Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84
Hide Description FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.
Time Frame Baseline and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study drug. Only those participants available at the indicated time point were assessed.
Arm/Group Title FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Hide Arm/Group Description:
Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
Overall Number of Participants Analyzed 350 356
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.168  (0.0121) 0.142  (0.0120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/VI 100/25 µg QD, FP/Salmeterol 250/50 µg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.025
Confidence Interval (2-Sided) 95%
-0.008 to 0.059
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Onset on Treatment Day 1
Hide Description Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.
Time Frame Baseline and Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Hide Arm/Group Description:
Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
Overall Number of Participants Analyzed 411 416
Median (Full Range)
Unit of Measure: Minutes
15
(5 to 240)
15
(5 to 240)
3.Secondary Outcome
Title Change From Baseline in Trough FEV1 on Treatment Day 85
Hide Description FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Hide Arm/Group Description:
Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
Overall Number of Participants Analyzed 364 369
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.151  (0.0126) 0.121  (0.0125)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 12 weeks).
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who were randomized and received at least one dose of study drug.
 
Arm/Group Title FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Hide Arm/Group Description Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study. Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
All-Cause Mortality
FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   13/412 (3.16%)   20/416 (4.81%) 
Cardiac disorders     
Cardiac failure  1  0/412 (0.00%)  1/416 (0.24%) 
Cardiac failure chronic  1  0/412 (0.00%)  1/416 (0.24%) 
Cardiac failure congestive  1  1/412 (0.24%)  0/416 (0.00%) 
Cor pulmonale  1  0/412 (0.00%)  1/416 (0.24%) 
Coronary artery disease  1  0/412 (0.00%)  1/416 (0.24%) 
Myocardial infarction  1  1/412 (0.24%)  0/416 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/412 (0.24%)  0/416 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/412 (0.00%)  1/416 (0.24%) 
Infections and infestations     
Pneumonia  1  1/412 (0.24%)  4/416 (0.96%) 
Infective exacerbation of chronic obstructive airways diseas  1  0/412 (0.00%)  3/416 (0.72%) 
Cellulitis  1  0/412 (0.00%)  1/416 (0.24%) 
Clostridium difficile colitis  1  0/412 (0.00%)  1/416 (0.24%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/412 (0.00%)  1/416 (0.24%) 
Femoral neck fracture  1  0/412 (0.00%)  1/416 (0.24%) 
Fibula fracture  1  1/412 (0.24%)  0/416 (0.00%) 
Mouth injury  1  1/412 (0.24%)  0/416 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon neoplasm  1  0/412 (0.00%)  1/416 (0.24%) 
Small cell lung cancer  1  0/412 (0.00%)  1/416 (0.24%) 
Squamous cell carcinoma of lung  1  1/412 (0.24%)  0/416 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/412 (0.24%)  0/416 (0.00%) 
Convulsion  1  1/412 (0.24%)  0/416 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  5/412 (1.21%)  4/416 (0.96%) 
Haemoptysis  1  0/412 (0.00%)  1/416 (0.24%) 
Pneumothorax  1  0/412 (0.00%)  1/416 (0.24%) 
Vascular disorders     
Hypertensive crisis  1  1/412 (0.24%)  0/416 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
FF/VI 100/25 µg QD FP/Salmeterol 250/50 µg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   46/412 (11.17%)   52/416 (12.50%) 
Infections and infestations     
Nasopharyngitis  1  30/412 (7.28%)  26/416 (6.25%) 
Nervous system disorders     
Headache  1  18/412 (4.37%)  29/416 (6.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706328     History of Changes
Other Study ID Numbers: 116974
First Submitted: October 11, 2012
First Posted: October 15, 2012
Results First Submitted: January 23, 2014
Results First Posted: March 5, 2014
Last Update Posted: May 2, 2018