AsthmaPhase 3NCT01244984
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
A Phase 3 study testing Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder in people with Asthma, run by GlaxoSmithKline at 30 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 30 sitesJapan
- Study dates
- Jul 2010to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
GSK Investigational Site
Chiba, 277-0863
GSK Investigational Site
Fukuoka, 802-0083
GSK Investigational Site
Fukuoka, 816-0813
GSK Investigational Site
Gifu, 501-6062
GSK Investigational Site
Gunma, 373-0021
GSK Investigational Site
Hiroshima, 730-0844
GSK Investigational Site
Hiroshima, 732-0062
GSK Investigational Site
Hiroshima, 739-0402
GSK Investigational Site
Hyōgo, 665-0827
GSK Investigational Site
Hyōgo, 670-0046
GSK Investigational Site
Hyōgo, 672-8064
GSK Investigational Site
Ibaraki, 302-0022
GSK Investigational Site
Kanagawa, 231-8682
GSK Investigational Site
Kanagawa, 253-0041
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Kyoto, 615-8087
GSK Investigational Site
Miyagi, 983-0824
GSK Investigational Site
Miyagi, 983-8520
GSK Investigational Site
Nagano, 390-0303
GSK Investigational Site
Nagano, 390-8510
GSK Investigational Site
Okayama, 700-0862
GSK Investigational Site
Okayama, 701-0304
GSK Investigational Site
Okayama, 714-0081
GSK Investigational Site
Osaka, 545-8586
GSK Investigational Site
Osaka, 569-1192
GSK Investigational Site
Osaka, 589-0022
GSK Investigational Site
Tokyo, 105-0004
GSK Investigational Site
Tokyo, 134-0083
GSK Investigational Site
Tokyo, 185-0014
GSK Investigational Site
Toyama, 937-0066
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder
- Keywords
- asthma, Fluticasone furoate, GW642444
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/GW642444 Inhalation PowderDrug
Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Fluticasone Furoate Inhalation PowderDrug
Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate/GW642444 | Experimental | Combination inhaled corticosteroid and long-acting beta2-agonist Receives: Drug: Fluticasone Furoate/GW642444 Inhalation Powder |
| Fluticasone Furoate | Experimental | Inhaled corticosteroid Receives: Drug: Fluticasone Furoate Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
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.
Measured: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Secondary outcomes (22)
Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at 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.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.
Measured: 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
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.
Measured: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
Change From Baseline in the 24-hour Urinary Cortisol Excretion
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.
Measured: Baseline (Week 0), Week 24, and Week 52/WD
Change From Baseline in Blood Pressure
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.
Measured: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Change From Baseline in Heart Rate (HR)
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.
Measured: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
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.
Measured: Week 12, Week 24, and Week 52/WD
Number of Participants With Severe Asthma Exacerbation During the Study Treatment
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.
Measured: 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
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.
Measured: Baseline up to Week 52
Change From Baseline in Asthma Symptom Score During the Study Treatment
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.
Measured: Baseline up to Week 52
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment
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.
Measured: Baseline up to Week 52
Change From Baseline in the Percentage of Rescue-free 24-hour Periods
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.
Measured: Baseline up to Week 52
Number of Rescue Medication Inhalations
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).
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244984
- Sponsor's protocol ID
- 113989
- Status last verified
- Nov 2016
- First submitted
- 18 Nov 2010
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
PubMed 27881132
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01244984
- Acronym / sponsor ID
- 113989
- Conditions
- Asthma
- Keywords
- asthma, Fluticasone furoate, GW642444
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 9 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate/GW642444 | Experimental | Drug: Fluticasone Furoate/GW642444 Inhalation PowderCombination inhaled corticosteroid and long-acting beta2-agonist |
| Fluticasone Furoate | Experimental | Drug: Fluticasone Furoate Inhalation PowderInhaled corticosteroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Furoate/GW642444 Inhalation PowderFluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks | Drug | Fluticasone Furoate/GW642444 |
| Fluticasone Furoate Inhalation PowderFluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks | Drug | Fluticasone Furoate |
Primary outcome
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.
22 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Change From Baseline in the 24-hour Urinary Cortisol Excretion
Time frame: 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
Change From Baseline in Heart Rate (HR)
Time frame: 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
Number of Participants With Severe Asthma Exacerbation During the Study Treatment
Time frame: 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 Asthma Symptom Score During the Study Treatment
Time frame: 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
Change From Baseline in the Percentage of Rescue-free 24-hour Periods
Time frame: Baseline up to Week 52
Number of Rescue Medication Inhalations
Time frame: Baseline up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Derived from this study: PubMed 27881132O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder in people with Asthma, run by GlaxoSmithKline at 30 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.