Clinical trial NCT01244984: A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
Fluticasone furoate
GW642444
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
timeFrame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Secondary outcomes:
measure: Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: 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
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: 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
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: 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
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: 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
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD
timeFrame: Baseline (Week -2), Week 12, Week 24, and Week 52/WD
measure: Change From Baseline in the 24-hour Urinary Cortisol Excretion
timeFrame: Baseline (Week 0), Week 24, and Week 52/WD
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
measure: Change From Baseline in Heart Rate (HR)
timeFrame: Baseline (Week 0), Week 12, Week 24, and Week 52/WD
measure: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
timeFrame: Week 12, Week 24, and Week 52/WD
measure: Number of Participants With Severe Asthma Exacerbation During the Study Treatment
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Asthma Symptom Score During the Study Treatment
timeFrame: Baseline up to Week 52
measure: Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment
timeFrame: Baseline up to Week 52
measure: Change From Baseline in the Percentage of Rescue-free 24-hour Periods
timeFrame: Baseline up to Week 52
measure: Number of Rescue Medication Inhalations
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gifu
country: Japan
facility: GSK Investigational Site
city: Gunma
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Toyama
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: O'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.