Clinical trial NCT00269087: GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
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 -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Bronchitis
COPD
Emphysema
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Up to Week 56
Secondary outcomes:
measure: Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters
timeFrame: Up to Week 56
measure: Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters
timeFrame: Up to Week 56
measure: Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters
timeFrame: Up to Week 56
measure: Mean Change From Baseline in Level of Plasma Cortisol 1
timeFrame: Baseline and Week 24 and 52
measure: Mean Level of Plasma Cortisol 2
timeFrame: Up to Week 56
measure: Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline and up to Week 56
measure: Mean Change From Baseline in Pulse Rate
timeFrame: Baseline and up to Week 56
measure: Number of Participants With Abnormal Oropharyngeal Examination Findings
timeFrame: Up to Week 56
measure: Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings
timeFrame: Up to Week 56
measure: Mean Change From Baseline in Bone Mineral Density (BMD)
timeFrame: Baseline and up to Week 56
measure: Mean Change From Baseline in Weight
timeFrame: Baseline and up to Week 56
measure: Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings
timeFrame: Up to Week 56
measure: Mean Change From Baseline in Peak Expiratory Flow (PEF)
timeFrame: Baseline and up to Week 52
measure: Mean Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline and up to Week 52
measure: Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity
timeFrame: Baseline and up to Week 52
measure: Mean Change From Baseline in Percent of Days Without Use of Rescue Medication
timeFrame: Baseline and up to Week 52
measure: Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings
timeFrame: Baseline and up to Week 52
measure: Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: Up to Week 56
measure: Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP)
timeFrame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
measure: Mean Cmax of Salmeterol
timeFrame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
measure: Median Time of Observed Maximum Plasma Concentration (Tmax) of FP
timeFrame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
measure: Median Tmax of Salmeterol
timeFrame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
measure: Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP
timeFrame: Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours
measure: Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol
timeFrame: Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours
Other outcomes:
Locations:
city: Kodaira
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.