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Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents

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ClinicalTrials.gov Identifier: NCT01431950
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : September 3, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: fluticasone furoate
Drug: albuterol/salbutamol
Enrollment 238
Recruitment Details  
Pre-assignment Details Participants meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 500 participants were screened; 239 were randomized, and 238 received >=1 dose of study treatment.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed. Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Period Title: Overall Study
Started 119 119
Completed 100 104
Not Completed 19 15
Reason Not Completed
Study Site Closed/Terminated             7             3
Withdrawal by Subject             4             3
Protocol Violation             2             3
Adverse Event             2             2
Physician Decision             2             1
Lack of Efficacy             2             1
Lost to Follow-up             0             1
Met Protocol-defined Stopping Criteria             0             1
Arm/Group Title FF 100 µg OD FF 200 µg OD Total
Hide Arm/Group Description Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed. Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed. Total of all reporting groups
Overall Number of Baseline Participants 119 119 238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 119 participants 238 participants
46.6  (15.41) 45.1  (15.78) 45.9  (15.58)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 119 participants 238 participants
Female
81
  68.1%
79
  66.4%
160
  67.2%
Male
38
  31.9%
40
  33.6%
78
  32.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 119 participants 238 participants
African American/African Heritage (HER) 5 4 9
Central/South Asian HER 1 0 1
Japanese/East Asian HER /South East Asian HER 0 3 3
Native Hawaiian or other Pacific Islander 1 0 1
White 101 100 201
American Indian or Alaska Native & White 11 12 23
1.Primary Outcome
Title Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
Hide Description FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description:
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Overall Number of Participants Analyzed 106 109
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.208  (0.0417) 0.284  (0.0411)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF 100 µg OD, FF 200 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.077
Confidence Interval 95%
-0.039 to 0.192
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period
Hide Description The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time Frame From Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description:
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of rescue-free 24-hr periods
21.3  (3.05) 23.1  (3.03)
3.Secondary Outcome
Title Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period
Hide Description PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time Frame From Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description:
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: Liters/minute (L/min)
5.9  (3.26) 7.2  (3.25)
4.Secondary Outcome
Title Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
Hide Description PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time Frame From Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description:
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: L/min
13.4  (3.22) 13.2  (3.20)
5.Secondary Outcome
Title Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period
Hide Description Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Time Frame From Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description:
Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of symptom-free 24-hr periods
17.5  (2.80) 19.6  (2.79)
Time Frame On-treatment adverse events (AEs), defined as those events occurring while participants were on treatment, up to and including the day after the last dose (up to 24 weeks), are reported.
Adverse Event Reporting Description Serious AEs (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
 
Arm/Group Title FF 100 µg OD FF 200 µg OD
Hide Arm/Group Description Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed. Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
All-Cause Mortality
FF 100 µg OD FF 200 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FF 100 µg OD FF 200 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   3/119 (2.52%)   4/119 (3.36%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/119 (0.00%)  1/119 (0.84%) 
Infections and infestations     
Abscess  1  0/119 (0.00%)  1/119 (0.84%) 
Acute sinusitis  1  1/119 (0.84%)  0/119 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chondromalacia  1  1/119 (0.84%)  0/119 (0.00%) 
Chondropathy  1  0/119 (0.00%)  1/119 (0.84%) 
Intervertebral disc protrusion  1  0/119 (0.00%)  1/119 (0.84%) 
Spondylolisthesis  1  0/119 (0.00%)  1/119 (0.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thymoma  1  0/119 (0.00%)  1/119 (0.84%) 
Renal and urinary disorders     
Cystitis haemorrhagic  1  1/119 (0.84%)  0/119 (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 100 µg OD FF 200 µg OD
Affected / at Risk (%) Affected / at Risk (%)
Total   52/119 (43.70%)   49/119 (41.18%) 
Infections and infestations     
Nasopharyngitis  1  14/119 (11.76%)  15/119 (12.61%) 
Bronchitis  1  14/119 (11.76%)  8/119 (6.72%) 
Influenza  1  5/119 (4.20%)  8/119 (6.72%) 
Sinusitis  1  8/119 (6.72%)  5/119 (4.20%) 
Pharyngitis  1  7/119 (5.88%)  4/119 (3.36%) 
Upper respiratory tract infection  1  2/119 (1.68%)  7/119 (5.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/119 (3.36%)  4/119 (3.36%) 
Nervous system disorders     
Headache  1  12/119 (10.08%)  15/119 (12.61%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  3/119 (2.52%)  5/119 (4.20%) 
Rhinitis allergic  1  5/119 (4.20%)  2/119 (1.68%) 
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: NCT01431950     History of Changes
Other Study ID Numbers: 114496
First Submitted: August 25, 2011
First Posted: September 12, 2011
Results First Submitted: August 21, 2014
Results First Posted: September 3, 2014
Last Update Posted: January 9, 2017