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Trial record 53 of 318 for:    FLUTICASONE AND SALMETEROL

Study to Evaluate 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

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ClinicalTrials.gov Identifier: NCT01323634
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : July 30, 2013
Last Update Posted : November 8, 2017
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
Enrollment 519
Recruitment Details  
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 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 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 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 Run-in Period
Started 733 0 0
Completed 521 0 0
Not Completed 212 0 0
Reason Not Completed
Inclusion/Exclusion Criteria not Met             125             0             0
Continuation Criteria not Met             73             0             0
Withdrawal by Subject             7             0             0
Physician Decision             5             0             0
Protocol Violation             1             0             0
Adverse Event             1             0             0
Period Title: Double-Blind (DB) Treatment Period
Started 0 260 261
Completed 0 235 239
Not Completed 0 25 22
Reason Not Completed
Adverse Event             0             8             4
Lack of Efficacy             0             0             2
Protocol Violation             0             6             7
Lost to Follow-up             0             1             1
Physician Decision             0             2             3
Withdrawal by Subject             0             7             4
Did not Receive DB Study Medication             0             1             1
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 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 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 259 260 519
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 259 participants 260 participants 519 participants
61.2  (8.32) 61.1  (7.92) 61.2  (8.11)
[1]
Measure Description: Baseline characteristic data are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 260 participants 519 participants
Female
90
  34.7%
96
  36.9%
186
  35.8%
Male
169
  65.3%
164
  63.1%
333
  64.2%
[1]
Measure Description: Baseline characteristic data are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 259 participants 260 participants 519 participants
African American/ African Heritage 9 5 14
American Indian or Alaska Native 0 1 1
White/Caucasian/European Heritage 250 254 504
[1]
Measure Description: Baseline characteristic data are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
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). 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 on Treatment Day 84. Baseline trough FEV1 was 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.
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 participants available at the indicated time point 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 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 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 213 228
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.094  (0.0158) 0.174  (0.0153)
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.080
Confidence Interval (2-Sided) 95%
0.037 to 0.124
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. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants available at the indicated time point 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 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 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 257 258
Median (Full Range)
Unit of Measure: Minutes
30
(5 to 240)
15
(5 to 240)
Time Frame Serious adverse events (SAEs) and non-serious adverse events were collected from Baseline to the end of the study (up to 12 weeks).
Adverse Event Reporting Description SAEs and non-serious adverse events are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
 
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 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 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   8/259 (3.09%)   3/260 (1.15%) 
Cardiac disorders     
Atrial fibrillation  1  1/259 (0.39%)  1/260 (0.38%) 
Cardiac failure congestive  1  1/259 (0.39%)  0/260 (0.00%) 
Cardio-respiratory arrest  1  1/259 (0.39%)  0/260 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/259 (0.00%)  1/260 (0.38%) 
Infections and infestations     
Bronchitis  1  1/259 (0.39%)  0/260 (0.00%) 
Injury, poisoning and procedural complications     
Rib fracture  1  1/259 (0.39%)  0/260 (0.00%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  0/259 (0.00%)  1/260 (0.38%) 
Synovial cyst  1  0/259 (0.00%)  1/260 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Chronic onstructive pulmonary disease  1  3/259 (1.16%)  0/260 (0.00%) 
Acute respiratory failure  1  0/259 (0.00%)  1/260 (0.38%) 
Epistaxis  1  1/259 (0.39%)  0/260 (0.00%) 
Pulmonary embolism  1  0/259 (0.00%)  1/260 (0.38%) 
Vascular disorders     
Deep vein thrombosis  1  0/259 (0.00%)  1/260 (0.38%) 
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   18/259 (6.95%)   23/260 (8.85%) 
Infections and infestations     
Nasopharyngitis  1  7/259 (2.70%)  8/260 (3.08%) 
Nervous system disorders     
Headache  1  11/259 (4.25%)  16/260 (6.15%) 
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: NCT01323634     History of Changes
Other Study ID Numbers: 113109
First Submitted: March 17, 2011
First Posted: March 25, 2011
Results First Submitted: May 30, 2013
Results First Posted: July 30, 2013
Last Update Posted: November 8, 2017