A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT01244984

Recruitment Status : Completed

First Posted : November 22, 2010

Results First Posted : August 9, 2013

Last Update Posted : January 11, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Fluticasone Furoate/GW642444 Inhalation Powder Drug: Fluticasone Furoate Inhalation Powder	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	243 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and FF Inhalation Powder in Japanese Subjects With Asthma
Study Start Date :	July 2010
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fluticasone Furoate/GW642444 Combination inhaled corticosteroid and long-acting beta2-agonist	Drug: Fluticasone Furoate/GW642444 Inhalation Powder Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Experimental: Fluticasone Furoate Inhaled corticosteroid	Drug: Fluticasone Furoate Inhalation Powder Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks

Outcome Measures

Primary Outcome Measures :

Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) [ Time Frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) ]
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE.

Secondary Outcome Measures :

Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD [ Time Frame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD ]
Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.
Change From Baseline in the 24-hour Urinary Cortisol Excretion [ Time Frame: Baseline (Week 0), Week 24, and Week 52/WD ]
Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.
Change From Baseline in Blood Pressure [ Time Frame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD ]
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in Heart Rate (HR) [ Time Frame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD ]
Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings [ Time Frame: Week 12, Week 24, and Week 52/WD ]
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.
Number of Participants With Severe Asthma Exacerbation During the Study Treatment [ Time Frame: Baseline up to Week 52 ]
A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.
Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment [ Time Frame: Baseline up to Week 52 ]
Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.
Change From Baseline in Asthma Symptom Score During the Study Treatment [ Time Frame: Baseline up to Week 52 ]
The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment [ Time Frame: Baseline up to Week 52 ]
Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.
Change From Baseline in the Percentage of Rescue-free 24-hour Periods [ Time Frame: Baseline up to Week 52 ]
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.
Number of Rescue Medication Inhalations [ Time Frame: Baseline up to Week 52 ]
Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Out patient at least 18 years of age
Both genderds; females of childbearing potential must be willing to use birth control method
A diagnosis of asthma at least 6 months prior to Screening
A best FEV1 of at least 50% of the predicted nomal value at Screening
Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening

Exclusion Criteria:

History of life-threating asthma
Respiratory infection or oral candidiasis
Asthma exacerbation within 12 weeks
Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
Allergies to study drugs, study drugs7 excipients, medications related to study drugs
Taking another investigational medication or medication prohibited for use during this study

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244984

Locations

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Japan
GSK Investigational Site
Chiba, Japan, 277-0863
GSK Investigational Site
Fukuoka, Japan, 802-0083
GSK Investigational Site
Fukuoka, Japan, 816-0813
GSK Investigational Site
Gifu, Japan, 501-6062
GSK Investigational Site
Gunma, Japan, 373-0021
GSK Investigational Site
Hiroshima, Japan, 730-0844
GSK Investigational Site
Hiroshima, Japan, 732-0062
GSK Investigational Site
Hiroshima, Japan, 739-0402
GSK Investigational Site
Hyogo, Japan, 665-0827
GSK Investigational Site
Hyogo, Japan, 670-0046
GSK Investigational Site
Hyogo, Japan, 672-8064
GSK Investigational Site
Ibaraki, Japan, 302-0022
GSK Investigational Site
Kanagawa, Japan, 231-8682
GSK Investigational Site
Kanagawa, Japan, 253-0041
GSK Investigational Site
Kyoto, Japan, 601-1495
GSK Investigational Site
Kyoto, Japan, 615-8087
GSK Investigational Site
Miyagi, Japan, 983-0824
GSK Investigational Site
Miyagi, Japan, 983-8520
GSK Investigational Site
Nagano, Japan, 390-0303
GSK Investigational Site
Nagano, Japan, 390-8510
GSK Investigational Site
Okayama, Japan, 700-0862
GSK Investigational Site
Okayama, Japan, 701-0304
GSK Investigational Site
Okayama, Japan, 714-0081
GSK Investigational Site
Osaka, Japan, 545-8586
GSK Investigational Site
Osaka, Japan, 569-1192
GSK Investigational Site
Osaka, Japan, 589-0022
GSK Investigational Site
Tokyo, Japan, 105-0004
GSK Investigational Site
Tokyo, Japan, 134-0083
GSK Investigational Site
Tokyo, Japan, 185-0014
GSK Investigational Site
Toyama, Japan, 937-0066

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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