This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The study population will include patients hospitalized for an acute exacerbation of COPD. The target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency room visit or physician's office visit for an exacerbation of COPD requiring treatment with oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination). Related efficacy endpoints include, time to first exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16) and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS); and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT). Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety will be assessed by monitoring of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
639
Fluticasone propionate/salmeterol 250/50 mcg BID in the DISKUS formulation (ADVAIR DISKUS) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, indicated in the US for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD.
Salmeterol xinafoate Inhalation Powder (SEREVENT DISKUS) is indicated for the long-term, twice-daily (morning and evening), administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Florence, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Anchorage, Alaska, United States
Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)
A COPD exacerbation (EX) was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur \>21 days post-discharge/physician's office visit for a prior COPD EX.
Time frame: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.
Time frame: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.
Time frame: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).
Time frame: From Baseline up to Week 29, approximately
Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).
Time frame: From Baseline up to Week 29, approximately
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GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Fresno, California, United States
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