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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01192191
First received: August 30, 2010
Last updated: June 6, 2013
Last verified: April 2013
  Purpose

The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period [ Time Frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) ] [ Designated as safety issue: No ]
    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 SAEs.

  • Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period [ Time Frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) ] [ Designated as safety issue: No ]
    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. Relatedness was assessed by the investigator.


Secondary Outcome Measures:
  • Number of Participants With Pneumonia During the Treatment Period [ Time Frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]) ] [ Designated as safety issue: No ]
    Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or 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 ot

  • Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) [ Time Frame: Baseline (Week -2), and Week 52/Withdrawal (WD) ] [ Designated as safety issue: No ]
    Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.

  • Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD) [ Time Frame: Baseline (Week -2), and Week 52/Withdrawal (WD ] [ Designated as safety issue: No ]
    Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.

  • Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD) [ Time Frame: Baseline (Week -2), Week 52/Withdrawal (WD) ] [ Designated as safety issue: No ]
    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, 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 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD) [ Time Frame: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD) ] [ Designated as safety issue: No ]
    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 post-Baseline value minus the Baseline value.

  • Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD ] [ Designated as safety issue: No ]
    Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; 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) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD ] [ Designated as safety issue: No ]
    Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; 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: Baseline (Week -2), Week 12, Week 24, and Week 52 ] [ Designated as safety issue: No ]
    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 (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.


Enrollment: 187
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Experimental: Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out patient at least 40 years of age
  • Both genders; females childbearing potencial must be willing to use birth control method
  • A diagnosis of COPD at Screening
  • Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
  • Post-bronchodilator FEV1/FVC ratio of less than 70%
  • Post-bronchodilator FEV1 of less than 80%

Exclusion Criteria:

  • Current diagnosis of sthma
  • Respiratory disorders other than COPD
  • Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
  • Concurrent other disease that would confound study participation or affect subject safety
  • Allergies to study drugs, study drugs' excipients, medications related to study drugs
  • Taking another investigational medication or medication prohibited for use during this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192191

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 811-2201
GSK Investigational Site
Fukuoka, Japan, 819-8555
GSK Investigational Site
Fukushima, Japan, 964-0871
GSK Investigational Site
Gunma, Japan, 371-0048
GSK Investigational Site
Hiroshima, Japan, 732-0057
GSK Investigational Site
Hokkaido, Japan, 001-0901
GSK Investigational Site
Hokkaido, Japan, 064-0915
GSK Investigational Site
Hokkaido, Japan, 070-8644
GSK Investigational Site
Hyogo, Japan, 651-0073
GSK Investigational Site
Ibaraki, Japan, 310-0015
GSK Investigational Site
Ibaraki, Japan, 300-0053
GSK Investigational Site
Ishikawa, Japan, 920-8610
GSK Investigational Site
Kagawa, Japan, 763-8502
GSK Investigational Site
Kagawa, Japan, 760-0073
GSK Investigational Site
Kanagawa, Japan, 239-0821
GSK Investigational Site
Kyoto, Japan, 615-8087
GSK Investigational Site
Kyoto, Japan, 601-1495
GSK Investigational Site
Miyagi, Japan, 984-8560
GSK Investigational Site
Miyagi, Japan, 981-8563
GSK Investigational Site
Nagano, Japan, 391-0011
GSK Investigational Site
Nagano, Japan, 390-0303
GSK Investigational Site
Nagano, Japan, 390-8601
GSK Investigational Site
Nagano, Japan, 390-0832
GSK Investigational Site
Oita, Japan, 876-0047
GSK Investigational Site
Oita, Japan, 870-0921
GSK Investigational Site
Okayama, Japan, 701-0304
GSK Investigational Site
Osaka, Japan, 530-0012
GSK Investigational Site
Osaka, Japan, 545-8586
GSK Investigational Site
Osaka, Japan, 589-0022
GSK Investigational Site
Osaka, Japan, 576-0016
GSK Investigational Site
Tokyo, Japan, 185-0014
GSK Investigational Site
Tokyo, Japan, 187-0024
GSK Investigational Site
Toyama, Japan, 930-0194
GSK Investigational Site
Wakayama, Japan, 641-8510
GSK Investigational Site
Yamanashi, Japan, 400-0031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01192191     History of Changes
Other Study ID Numbers: 114156
Study First Received: August 30, 2010
Results First Received: June 6, 2013
Last Updated: June 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
GW642444
COPD
Fluticasone Furoate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 18, 2014