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Trial record 61 of 318 for:    FLUTICASONE AND SALMETEROL

A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

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ClinicalTrials.gov Identifier: NCT01342913
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : July 30, 2013
Last Update Posted : August 31, 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/Vilanterol 25mcg
Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Enrollment 528
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 Salmeterol/FP 50/500 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 Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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 702 0 0
Completed 528 0 0
Not Completed 174 0 0
Reason Not Completed
Inclusion/Exclusion Criteria Not Met             66             0             0
Physician Decision             6             0             0
Withdrawal by Subject             7             0             0
Adverse Event             2             0             0
Protocol Violation             5             0             0
Continuation Criteria Not Met             88             0             0
Period Title: Double-Blind Treatment Period
Started 0 262 266
Completed 0 246 243
Not Completed 0 16 23
Reason Not Completed
Adverse Event             0             3             6
Lack of Efficacy             0             2             3
Protocol Violation             0             6             9
Lost to Follow-up             0             1             3
Physician Decision             0             2             0
Withdrawal by Subject             0             2             2
Arm/Group Title Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD Total
Hide Arm/Group Description Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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 262 266 528
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 262 participants 266 participants 528 participants
62.9  (9.07) 63.0  (8.10) 62.9  (8.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 262 participants 266 participants 528 participants
Female
41
  15.6%
54
  20.3%
95
  18.0%
Male
221
  84.4%
212
  79.7%
433
  82.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 262 participants 266 participants 528 participants
African American/African Heritage 1 0 1
Asian-South East Asian Heritage 53 48 101
White-Arabic/North African Hertage 2 1 3
White/Caucasian/European Heritage 206 217 423
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 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 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 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were assessed.
Arm/Group Title Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description:
Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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 233 224
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.108  (0.0145) 0.130  (0.0148)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salmeterol/FP 50/500 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 0.282
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.022
Confidence Interval (2-Sided) 95%
-0.018 to 0.063
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, 15 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 Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description:
Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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 260 260
Median (Full Range)
Unit of Measure: Minutes
28
(5 to 240)
16
(5 to 240)
3.Secondary Outcome
Title Change From Baseline in Trough FEV1 on Treatment Day 85
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined 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.
Time Frame Baseline and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants available at the indicated time point were assessed.
Arm/Group Title Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description:
Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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 245 242
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.088  (0.0154) 0.111  (0.0155)
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 All AEs and SAEs were followed until resolution, until the condition stabilized, until the event was otherwise explained, or until the participant was lost to follow-up.
 
Arm/Group Title Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Hide Arm/Group Description Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 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
Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   3/262 (1.15%)   6/266 (2.26%) 
Cardiac disorders     
Atrial fibrillation  1  0/262 (0.00%)  2/266 (0.75%) 
Angina pectoris  1  0/262 (0.00%)  1/266 (0.38%) 
Coronary artery disease  1  0/262 (0.00%)  1/266 (0.38%) 
Gastrointestinal disorders     
Food poisoning  1  0/262 (0.00%)  1/266 (0.38%) 
Infections and infestations     
Pneumonia  1  2/262 (0.76%)  1/266 (0.38%) 
Infective exacerbation of chronic obstructive airways diseas  1  0/262 (0.00%)  1/266 (0.38%) 
Sialoadenitis  1  1/262 (0.38%)  0/266 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal cancer  1  0/262 (0.00%)  1/266 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/262 (0.00%)  1/266 (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%
Salmeterol/FP 50/500 µg BID FF/VI 100/25 µg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   30/262 (11.45%)   32/266 (12.03%) 
Infections and infestations     
Nasopharyngitis  1  12/262 (4.58%)  8/266 (3.01%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/262 (1.15%)  10/266 (3.76%) 
Nervous system disorders     
Headache  1  18/262 (6.87%)  20/266 (7.52%) 
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: NCT01342913     History of Changes
Other Study ID Numbers: 113107
First Submitted: April 14, 2011
First Posted: April 27, 2011
Results First Submitted: May 30, 2013
Results First Posted: July 30, 2013
Last Update Posted: August 31, 2018