Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    


Intervention name(s): ADVAIR DISKUS 250/50 mg BID; SEREVENT 50 mcg BID
Intervention type(s): Drug; Drug
Intervention description(s): 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).
Other intervention name(s): FSC 250/50 mcg; Salmeterol xinafoate 50 mcg
Intervention MeSH terms: Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hospitalization; Exacerbations of COPD; Chronic Obstructive Pulmonary Disease (COPD)