In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Pulmonary - COPD
Title
A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product ADVAIR DISKUS in Comparison to SEREVENT DISKUS on the Exacerbationrate COPD Following Hospitalization (Pulmonary -COPD)
Description
This study will compare two drugs for the prevention of worsening symptoms of COPD. COPD stands for chronic obstructive pulmonary disease. Both of these drugs are FDA approved for the prevention of worsening symptoms of COPD. This study is blinded, which means the patient nor the doctor will know which drug the patient has been assigned to. All the patients will be given a rescue inhaler to use during the study. Patients will be in the study for 9 months and will be seen in their study doctors office for at least 6 visits.
IRB Number
Pro2039
Inclusion/Notes
INCLUSION:
Male or female of =40 years of age at screening.
Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control• Current or former smokers with a >10 pack-year cigarette smoking history.
Patients hospitalized for a duration not exceeding 10 days due to an acute
exacerbation of COPD.
Patients with COPD who were treated and held for observation in the emergency
department (i.e. emergency room, ER) for at least 24 hours due to an acute
exacerbation of COPD.
Patients who received oral corticosteroids or oral corticosteroids and antibiotics for
treatment of an exacerbation of COPD during a physician’s office visit and who have been hospitalized within the
previous six months due to an acute exacerbation of COPD.
EXCLUSION:
Diagnosis of pneumonia, congestive heart failure (CHF), or other complicating comorbid
A previous lung resection surgery (e.g. lobectomy, pneumonectomy, etc) within
the year preceding Visit 1 (Screening)
Asthma as primary diagnosis
Lung cancer
Cystic fibrosis, pulmonary fibrosis, active tuberculosis, or sarcoidosis
Uncontrolled hypertension
Current malignancy or a previous history of cancer in remission for < 5yrs
(localized basal cell or squamous cell carcinoma of the skin that has been
