Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 85
Updated:11/10/2017
Start Date:April 30, 2010
End Date:May 8, 2012

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A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization

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.


Inclusion Criteria:

Subjects eligible for enrolment in this study must meet all of the following criteria:

- Male or female of at least 40 years of age at screening.

To be eligible for entry into the study, females of childbearing potential must commit to
the consistent and correct use of an acceptable method of birth control starting on the day
of visit 1, throughout the clinical trial, and for a period after the trial to account for
elimination of the drug (minimum of six days), as defined by any one of the following:

- Abstinence Females of childbearing potential who are not sexually active must commit
to complete abstinence from intercourse

- Oral contraceptive (either combined estrogen/progestin or progestin only)

- Injectable progestogen

- Implants of levonorgestrel or etonogestrel

- Percutaneous contraceptive patches

- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate
of less than 1% per year,

- Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the
female subject's entry into the study and is the sole sexual partner for that female
subject, or

- Double-barrier method; condom or occlusive cap (diaphragm or cervical /vault caps)
plus spermicide.

- Current or former smokers with a >10 pack-year cigarette smoking history [number of
pack years = (number of cigarettes per day / 20) X number of years smoked (e.g., 10
pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day
for 20 years]. Former smokers are defined as those who have quit smoking for at least
3 months prior to the screening visit.

- Any of the following populations:

- Patients hospitalized for a duration not exceeding 10 days due to an acute
exacerbation of COPD, and who must be randomized within 10 days post-discharge.

- 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, and who must be randomized within 10 days post-discharge.

- 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 must be
randomized within 10 days of the visit, and who have been hospitalized within the
previous six months due to an acute exacerbation of COPD.

- Clinical diagnosis of COPD (for at least 6 months). The following definition of COPD
from the American Thoracic Society (ATS) will be used: COPD is a disease state
characterized by the presence of airflow obstruction due to chronic bronchitis or
emphysema; the airflow obstruction is generally progressive, may be accompanied by
airway hyper-reactivity, and may be partially reversible [American Thoracic Society,
1995].

- Documented evidence (within a year prior to Visit 1) in the medical chart of
spirometry confirming the diagnosis of COPD and/or spirometry performed prior to
randomization (Visit 2) that confirms pre-bronchodilator FEV1/FVC ratio less than or
equal to 0.70 and pre-bronchodilator FEV1 <70% of predicted.

- Review and subject's completion of written informed consent: a subject-signed and
dated written informed consent (form) must be obtained prior to any study procedure,
and the subject must be willing to comply with all the requirements of the study
protocol.

- Subject must be able to read, comprehend, and record information in English or
Spanish.

Exclusion Criteria:

- Subjects meeting any of the following criteria must not be enrolled in the study:

- Diagnosis of pneumonia, congestive heart failure (CHF), or other complicating
co-morbid condition while hospitalized within the last 6 months for an exacerbation of
COPD.

- Historical or current evidence of clinically significant uncontrolled disease
including, but not limited to, those listed below. Significant is defined as any
disease that, in the opinion of the investigator, would put the safety of the subjects
at risk through study participation, or which would affect the safety analysis or
other analyses if the disease/condition exacerbated during the study.

- 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

- Clinically significant cardiac arrhythmias

- Uncontrolled hypertension

- Unstable angina

- 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 resected is not
excluded)

- Uncontrolled diabetes mellitus

- Uncontrolled hyperthyroidism or hypothyroidism

- Immunologic compromise

- Cushing's or Addison's disease

- An abnormal 12-lead electrocardiogram (ECG) at Visit 1 (Screening) deemed to be
clinically significant by the investigator.

- A chest X-ray or computed tomography (CT) scan performed in the 6 months preceding
Visit 1 that revealed evidence of clinically significant abnormalities not believed to
be due to the presence of COPD. If the subject does not have a record of a chest
X-ray, one must be obtained and reviewed prior to randomization.

- Female patients with a positive urine pregnancy test at Visit 1.

- Any infirmity, physical disability, or geographic location that would limit compliance
for scheduled visits.

- Any adverse reaction, immediate or delayed, hypersensitivity to any Beta-agonist,
sympathomimetic drug, or corticosteroid including any components of the study drug
formulations.

- Limited ability to provide a valid informed consent due to psychiatric disease,
intellectual deficiency, poor motivation, current substance abuse (including illicit
drugs and alcohol), or neurological disorders that might interfere with completion of
study procedures or hearing problems that may impede effective communication.

- Study site staff (i.e. participating investigator, sub-investigator, study
coordinator, employee of the participating investigator) or family members of site
staffs.
We found this trial at
70
sites
North Syracuse, New York 13212
2320
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North Syracuse, NY
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Abingdon, Virginia 24210
2025
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Abingdon, VA
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Anchorage, Alaska 99508
2341
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Bahía Blanca, Buenos Aires
6113
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Bahía Blanca,
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Baltimore, Maryland 21201
2301
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Bay Pines, Florida 33744
2121
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Belleville, Illinois 62220
1584
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Birmingham, Alabama 35249
1777
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Birmingham, AL
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Brandon, Florida 33511
2146
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Brandon, FL
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Buffalo, New York 14263
2181
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Canton, Ohio 44708
2043
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Canton, OH
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Charleston, South Carolina 29425
2184
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Charlotte, North Carolina 28203
2100
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Cincinnati, Ohio 45229
1880
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Clearwater, Florida 33759
2122
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Clearwater, FL
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Cocoa, Florida 32927
2217
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Columbia, Maryland 21044
2287
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Corsicana, Texas 75110
1252
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Council Bluffs, Iowa 51503
1304
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Dallas, Texas 75230
1223
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Dayton, Ohio 45420
1900
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Dayton, OH
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Durham, North Carolina 27705
2198
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Durham, NC
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Easley, South Carolina 29640
2007
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Elizabeth City, North Carolina 27909
2344
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Fairfax, Virginia 22031
2267
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Florence, Alabama 35630
1724
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Fort Lauderdale, Florida 33308
2315
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Fort Mill, South Carolina 29707
2104
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Fresno, California 93720
216
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Fridley, Minnesota 55432
1512
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Gaffney, South Carolina 29340
2058
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Gainesville, Florida 32610
2105
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Glendale, Arizona 85304
336
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Greenville, South Carolina 29615
2022
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Hartford, Connecticut 06105
2496
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Houston, Texas 77030
1357
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Kansas City, Missouri 64128
1343
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Kissimmee, Florida 34741
2187
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Lawrenceville, Georgia 30046
1939
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Lincoln, Nebraska 68510
1258
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Livonia, Michigan 48154
1951
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Loma Linda, California 92357
43
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Long Beach, California 90813
22
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Minneapolis, Minnesota 55404
1509
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Mobile, Alabama 36617
1754
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Newport Beach, California 92663
31
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Oklahoma City, Oklahoma 73112
1161
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Omaha, Nebraska 68131
1299
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Orlando, Florida 32806
2186
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Philadelphia, Pennsylvania 19104
2373
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Phoenix, Arizona 85012
343
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Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97227
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Richmond, Virginia 23298
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Riverside, California 92506
37
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Saint Louis, Missouri 63110
1570
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San Diego, California 92111
99
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Seneca, South Carolina 29678
1989
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Sepulveda, California 91343
29
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Spartanburg, South Carolina 29303
2042
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Spokane, Washington 99208
947
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Statesville, North Carolina 28625
2093
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Torrance, California 90502
22
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Tucson, Arizona 85724
427
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Union, South Carolina 29379
2067
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Washington, D.C., District of Columbia 20007
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Wichita, Kansas 67207
1186
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Wilmington, North Carolina 28405
2282
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Winston-Salem, North Carolina 27103
2122
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Winter Park, Florida 32789
2184
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