- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244984
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
November 23, 2016 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
243
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chiba, Japan, 277-0863
- GSK Investigational Site
-
Fukuoka, Japan, 816-0813
- GSK Investigational Site
-
Fukuoka, Japan, 802-0083
- 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, 672-8064
- GSK Investigational Site
-
Hyogo, Japan, 670-0046
- 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, 701-0304
- GSK Investigational Site
-
Okayama, Japan, 700-0862
- GSK Investigational Site
-
Okayama, Japan, 714-0081
- GSK Investigational Site
-
Osaka, Japan, 545-8586
- GSK Investigational Site
-
Osaka, Japan, 589-0022
- GSK Investigational Site
-
Osaka, Japan, 569-1192
- GSK Investigational Site
-
Tokyo, Japan, 185-0014
- GSK Investigational Site
-
Tokyo, Japan, 134-0083
- GSK Investigational Site
-
Tokyo, Japan, 105-0004
- GSK Investigational Site
-
Toyama, Japan, 937-0066
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
|
Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
|
Experimental: Fluticasone Furoate
Inhaled corticosteroid
|
Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Baseline (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.
|
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.
|
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.
|
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.
|
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.
|
Baseline (Week -2), Week 12, Week 24, 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.
|
Baseline (Week 0), Week 24, and Week 52/WD
|
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.
|
Baseline (Week 0), Week 12, Week 24, and Week 52/WD
|
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.
|
Baseline (Week 0), Week 12, Week 24, and Week 52/WD
|
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.
|
Week 12, Week 24, and Week 52/WD
|
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.
|
Baseline up to Week 52
|
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.
|
Baseline up to Week 52
|
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.
|
Baseline up to Week 52
|
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.
|
Baseline up to Week 52
|
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.
|
Baseline up to Week 52
|
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).
|
Baseline up to Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 18, 2010
First Submitted That Met QC Criteria
November 18, 2010
First Posted (Estimate)
November 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- 113989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Individual Participant Data Set
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 113989Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Fluticasone Furoate/GW642444 Inhalation Powder
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveJapan
-
GlaxoSmithKlineCompletedAsthmaUnited States, Germany, Japan, Romania, Russian Federation, Poland
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveJapan
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Japan, Romania, Russian Federation, Ukraine, Argentina, Poland, Czechia
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Japan, Russian Federation, Chile, Poland, Mexico, Estonia, Korea, Republic of, Philippines
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Argentina, Australia, Germany, Estonia, Chile, Netherlands, Peru, South Africa, Sweden, Mexico, United Kingdom, Italy, Philippines, Canada
-
GlaxoSmithKlineCompletedAsthmaUnited States, Germany, Japan, Romania, Ukraine, Poland
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Australia, Argentina, Germany, Spain, South Africa, Mexico, Peru, Netherlands, Canada, United Kingdom, Denmark, Chile, Italy, Sweden
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
GlaxoSmithKlineCompleted