DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fluticasone Furoate/GW642444 Inhalation Powder (Drug); Fluticasone Furoate Inhalation Powder (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)

Secondary outcome:

Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at 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

Laboratory Parameter of Hemoglobin at 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

Laboratory Parameter of Red Blood Cell Count at 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

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

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

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

Laboratory Parameter of Urine Potential of Hydrogen (pH) at 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

Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD

Change From Baseline in the 24-hour Urinary Cortisol Excretion

Change From Baseline in Blood Pressure

Change From Baseline in Heart Rate (HR)

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

Number of Participants With Severe Asthma Exacerbation During the Study Treatment

Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment

Change From Baseline in Asthma Symptom Score During the Study Treatment

Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment

Change From Baseline in the Percentage of Rescue-free 24-hour Periods

Number of Rescue Medication Inhalations

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Chiba 277-0863, Japan

GSK Investigational Site, Fukuoka 802-0083, Japan

GSK Investigational Site, Fukuoka 816-0813, Japan

GSK Investigational Site, Gifu 501-6062, Japan

GSK Investigational Site, Gunma 373-0021, Japan

GSK Investigational Site, Hiroshima 730-0844, Japan

GSK Investigational Site, Hiroshima 732-0062, Japan

GSK Investigational Site, Hiroshima 739-0402, Japan

GSK Investigational Site, Hyogo 665-0827, Japan

GSK Investigational Site, Hyogo 670-0046, Japan

GSK Investigational Site, Hyogo 672-8064, Japan

GSK Investigational Site, Ibaraki 302-0022, Japan

GSK Investigational Site, Kanagawa 231-8682, Japan

GSK Investigational Site, Kanagawa 253-0041, Japan

GSK Investigational Site, Kyoto 601-1495, Japan

GSK Investigational Site, Kyoto 615-8087, Japan

GSK Investigational Site, Miyagi 983-0824, Japan

GSK Investigational Site, Miyagi 983-8520, Japan

GSK Investigational Site, Nagano 390-0303, Japan

GSK Investigational Site, Nagano 390-8510, Japan

GSK Investigational Site, Okayama 700-0862, Japan

GSK Investigational Site, Okayama 701-0304, Japan

GSK Investigational Site, Okayama 714-0081, Japan

GSK Investigational Site, Osaka 545-8586, Japan

GSK Investigational Site, Osaka 569-1192, Japan

GSK Investigational Site, Osaka 589-0022, Japan

GSK Investigational Site, Tokyo 105-0004, Japan

GSK Investigational Site, Tokyo 134-0083, Japan

GSK Investigational Site, Tokyo 185-0014, Japan

GSK Investigational Site, Toyama 937-0066, Japan

Additional Information

Starting date: July 2010
Last updated: August 15, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017