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GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269087
First received: December 21, 2005
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: fluticasone propionate/salmeterol combination DISKUS
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)" A Long-term Treatment Study of GW815SF50/500µg in Chronic Obstructive Pulmonary Disease -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants with any adverse events (AEs) and serious AEs (SAEs) [ Time Frame: Up to Week 56 ]
    AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Safety Population defined as all participants who had received an investigational product even for once.


Secondary Outcome Measures:
  • Number of participants with abnormal (outliers from the normal range) hematology parameters [ Time Frame: Up to Week 56 ]
    Hematology parameters: Red blood cells (RBC), Hemoglobin (Hb), Hematocrit, Platelet count (PC), White blood cells (WBC), Basophils, Eosinophils, Neutrophils, Lymphocytes and Monocytes were presented as the outliers from the normal range as > upper limit and < lower limit. Only number of participants with hematology values outside normal range were presented.

  • Number of participants with abnormal (outliers from the normal range) clinical chemistry parameters [ Time Frame: Up to Week 56 ]
    Clinical chemistry parameters: Total bilirubin (TB), Alkaline phosphatase (Al-P), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Gamma-glutamyl transpeptidase (GTP), Lactate dehydrogenase (LDH), Total cholesterol (TC), Glucose, Creatinine, Blood urea nitrogen (BUN), Uric acid (UA), Sodium (Na), Potassium (K), Chloride (Cl) and Calcium (Ca) were presented as the outliers from the normal range as > upper limit and < lower limit. Only number of participants with clinical chemistry values outside normal range were presented.

  • Number of participants with abnormal (shift from Baseline) urinalysis parameters [ Time Frame: Up to Week 56 ]
    Urinalysis parameters: Urine protein, Glucose and Urobilinogen were presented as shift from Baseline. Only number of participants with urinalysis values more than Baseline values were presented.

  • Mean change from Baseline in level of plasma cortisol 1 [ Time Frame: Baseline and up to Week 56 ]
    On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 a.m. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

  • Mean change from Baseline in pulse rate [ Time Frame: Baseline and up to Week 56 ]
    Pulse rate was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

  • Mean change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Week 56 ]
    Systolic and diastolic BP was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

  • Mean level of plasma cortisol 2 [ Time Frame: Up to Week 56 ]
    On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 a.m. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry.

  • Number of participants with abnormal oropharyngeal examination findings [ Time Frame: Up to Week 56 ]
    Oropharyngeal examination was performed in participants with suspected oral infection (candidiasis).

  • Number of participants with abnormal (clinically significant) electrocardiogram (ECG) findings [ Time Frame: Up to Week 56 ]
    On each assessment day at Week 24, 52 and follow up 12-lead ECG was performed. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance.

  • Mean change from Baseline in bone mineral density (BMD) [ Time Frame: Baseline and up to Week 56 ]
    On each assessment day at Week 52 and follow up, lumber (L1-L4) BMD was determined with a BMD meter by the dual energy X-ray absorption (DEXA) method. Baseline value was the measurement taken during run-in period. Change from Baseline was any value post Baseline minus value at Baseline.

  • Mean change from Baseline in weight [ Time Frame: Baseline and up to Week 56 ]
    Body weight was measured during run-in period, at Week 24 and 52.

  • Mean change from Baseline in peak expiratory flow (PEF) [ Time Frame: Baseline and up to Week 52 ]
    PEF is the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value. Full analysis set (FAS) Population included all enrolled Population excluding those who had not received investigational product at all and those who had no available data regarding efficacy after starting treatment with investigational product.

  • Number of participants with abnormal (clinically significant) ophthalmological examinations findings [ Time Frame: Up to Week 56 ]
    On each assessment day at Week 24, 52 and follow up, ophthalmological examinations (vision, cornea, lens, intraocular pressure, fundus oculi) were performed to determine the presence or absence of glaucoma and cataract.

  • Mean change from Baseline in forced vital capacity (FVC) [ Time Frame: Baseline and up to Week 52 ]
    FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value.

  • Mean change from Baseline in maximal expiratory flow rate at 25% (V25) and 50% (V50) of vital capacity [ Time Frame: Baseline and up to Week 52 ]
    V25 and V 50 were measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value.

  • Mean change from Baseline in percent of days without use of rescue medication [ Time Frame: Baseline and up to Week 52 ]
    Rescue medication (salbutamol sulfate aerosol provided as an investigational product) was issued to a participant and, when necessary, a spacer at the start of the run-in period. At each time of entry in the Chronic Obstructive Pulmonary Disease (COPD) diary, a participant recorded the number of occasions of rescue medication inhaled in the previous 24 hours in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit2. Change from Baseline was any post Baseline value minus Baseline value.

  • Change from Baseline in symptom score with respect to breathlessness, cough, sputum and nighttime awakenings [ Time Frame: Baseline and up to Week 52 ]
    A participant recorded scores on the scale of 0 to 4 for breathlessness and nighttime awakenings, where 0 indicated no symptoms and 4 indicated severe symptoms; on the scale of 0 to 3 for cough and sputum production, where 0 indicated no symptoms and 3 indicated severe symptoms, in the 24 hours prior to each entry in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit2. Change from Baseline was any post Baseline value minus Baseline value.

  • Mean frequency of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: Up to Week 56 ]
    An exacerbation is defined as worsening of the patient's symptoms of cough, sputum production and breathlessness requiring a change in medication. When a moderate or severe COPD exacerbation was observed, details (date of onset, outcome, date of resolution/death, severity, medications provided for treatment, whether the COPD exacerbation required hospitalization, whether the COPD exacerbation required patient withdrawal from the study) were recorded.

  • Mean observed maximum plasma concentration (Cmax) of fluticasone propionate (FP) [ Time Frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 ]
    For analysis of pharmacokinetic (PK) parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants. All subjects evaluable for pharmacokinetic parameters will be included in the analysis.

  • Mean Cmax of Salmeterol [ Time Frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 ]
    For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.

  • Median time of observed maximum plasma concentration (tmax) of FP [ Time Frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 ]
    For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.

  • Median tmax of Salmeterol [ Time Frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 ]
    For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.

  • Mean area under the plasma concentration-time curve over a dosing interval [AUC(0-tau)] of FP [ Time Frame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 ]
    For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.

  • Mean area under the plasma concentration-time curve from zero up to the last quantifiable plasma concentration [AUC (0-t)] of Salmeterol [ Time Frame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 ]
    For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.


Enrollment: 122
Study Start Date: January 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of COPD.

Exclusion criteria:

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.
  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: NCT00269087

Locations
Japan
GSK Investigational Site
Kodaira, Japan, 187-0002
GSK Investigational Site
Kyoto, Japan, 612-0026
GSK Investigational Site
Osaka, Japan, 596-8501
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
This study has not been published in the scientific literature.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00269087     History of Changes
Other Study ID Numbers: SCO100648 
Study First Received: December 21, 2005
Last Updated: February 6, 2017

Keywords provided by GlaxoSmithKline:
Chronic Bronchitis
COPD
Emphysema

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections
Salmeterol Xinafoate
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 27, 2017