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Trial record 82 of 318 for:    FLUTICASONE AND SALMETEROL

Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01323621
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : February 6, 2014
Last Update Posted : February 15, 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: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg
Drug: Fluticasone Propionate 250mcg / salmeterol 50mcg
Drug: Double-dummy placebo
Drug: Salbutamol as needed
Enrollment 512
Recruitment Details  
Pre-assignment Details At Visit 1, eligible participants entered a 2-week, single blind (placebo) Run-In Period to obtain Baseline assessments of albuterol (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 Treatment Period.
Arm/Group Title Placebo + Salbutamol FSC 250/50 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (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 a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks. Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
Period Title: 2-week, Single-blind Run In Period
Started 739 0 0
Completed 511 0 0
Not Completed 228 0 0
Reason Not Completed
Not Met Inclusion/Exclusion Criteria             121             0             0
Physician Decision             7             0             0
Withdrawal by Subject             12             0             0
Protocol Violation             1             0             0
Lost to Follow-up             1             0             0
Did Not Meet Continuation Criteria             86             0             0
Period Title: 12-week, Double-blind Treatment Period
Started 0 252 259
Completed 0 237 239
Not Completed 0 15 20
Reason Not Completed
Adverse Event             0             1             5
Lack of Efficacy             0             2             6
Protocol Violation             0             4             4
Lost to Follow-up             0             1             0
Physician Decision             0             2             1
Withdrawal by Subject             0             5             4
Arm/Group Title FSC 250/50 µg BID FF/VI 100/25 µg QD Total
Hide Arm/Group Description Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks. Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 252 259 511
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 252 participants 259 participants 511 participants
61.7  (9.05) 61.6  (9.59) 61.6  (9.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 252 participants 259 participants 511 participants
Female
85
  33.7%
78
  30.1%
163
  31.9%
Male
167
  66.3%
181
  69.9%
348
  68.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 252 participants 259 participants 511 participants
White - White/Caucasian/European Heritage 238 241 479
African American/African Heritage 14 17 31
White - Arabic/North African Heritage 0 1 1
1.Primary Outcome
Title Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount 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 at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.
Time Frame Baseline (Day 1) and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only those participants available at the indicated time points were assessed.
Arm/Group Title FSC 250/50 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description:
Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
Overall Number of Participants Analyzed 217 219
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.114  (0.0183) 0.142  (0.0182)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC 250/50 µg BID, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.029
Confidence Interval 95%
-0.022 to 0.080
Estimation Comments ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.
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. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
Time Frame Baseline and Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title FSC 250/50 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description:
Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
Overall Number of Participants Analyzed 251 258
Median (Full Range)
Unit of Measure: Minutes
30
(5 to 240)
16
(5 to 240)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FSC 250/50 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks. Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
All-Cause Mortality
FSC 250/50 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FSC 250/50 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   3/252 (1.19%)   5/259 (1.93%) 
Cardiac disorders     
Cardiac failure  1  0/252 (0.00%)  1/259 (0.39%) 
Myocardial infarction  1  0/252 (0.00%)  1/259 (0.39%) 
Infections and infestations     
Infective tenosynovitis  1  0/252 (0.00%)  1/259 (0.39%) 
Injury, poisoning and procedural complications     
Comminuted fracture  1  1/252 (0.40%)  0/259 (0.00%) 
Wrist fracture  1  1/252 (0.40%)  0/259 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung adenocarcinoma metastatic  1  0/252 (0.00%)  1/259 (0.39%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/252 (0.00%)  1/259 (0.39%) 
Bronchitis chronic  1  0/252 (0.00%)  1/259 (0.39%) 
Chronic obstructive pulmonary disease  1  0/252 (0.00%)  1/259 (0.39%) 
Pulmonary embolism  1  1/252 (0.40%)  0/259 (0.00%) 
Respiratory failure  1  0/252 (0.00%)  1/259 (0.39%) 
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%
FSC 250/50 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   10/252 (3.97%)   12/259 (4.63%) 
Nervous system disorders     
Headache  1  10/252 (3.97%)  12/259 (4.63%) 
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: NCT01323621     History of Changes
Other Study ID Numbers: 112352
First Submitted: March 17, 2011
First Posted: March 25, 2011
Results First Submitted: May 30, 2013
Results First Posted: February 6, 2014
Last Update Posted: February 15, 2018