Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
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
1 other identifier
interventional
639
3 countries
103
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2010
Typical duration for phase_4
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Start
First participant enrolled
April 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2012
CompletedResults Posted
Study results publicly available
January 18, 2013
CompletedNovember 8, 2017
October 1, 2017
1.9 years
April 22, 2010
December 13, 2012
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
Secondary Outcomes (2)
Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization
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)
From Baseline up to Week 29, approximately
Study Arms (2)
ADVAIR DISKUS 250/50 mcg BID
ACTIVE COMPARATORFluticasone 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.
Serevent 50 mcg BID
ACTIVE COMPARATORSalmeterol 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (103)
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Florence, Alabama, 35630, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Anchorage, Alaska, 99508, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Phoenix, Arizona, 85023, United States
GSK Investigational Site
Tucson, Arizona, 85710, United States
GSK Investigational Site
Fresno, California, 93702, United States
GSK Investigational Site
Loma Linda, California, 92357, United States
GSK Investigational Site
Long Beach, California, 90822, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
Sepulveda, California, 91343, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Gainesville, Florida, 32608, United States
GSK Investigational Site
Kissimmee, Florida, 34741, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Winter Park, Florida, 32792, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Belleville, Illinois, 62220, United States
GSK Investigational Site
Council Bluffs, Iowa, 51503, United States
GSK Investigational Site
Wichita, Kansas, 67218, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Livonia, Michigan, 48152, United States
GSK Investigational Site
Fridley, Minnesota, 55432, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Kansas City, Missouri, 64128, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68506, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
Buffalo, New York, 14215-1199, United States
GSK Investigational Site
North Syracuse, New York, 13212, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Dayton, Ohio, 45459, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Portland, Oregon, 97220, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15025, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Fort Mill, South Carolina, 29707, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Seneca, South Carolina, 29678, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Dallas, Texas, 75216, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Fairfax, Virginia, 22030, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Bahía Blanca, Buenos Aires, B8000AAK, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425DQI, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ, Argentina
GSK Investigational Site
San Juan Bautista, Buenos Aires, 1888, Argentina
GSK Investigational Site
Comodoro Rivadavia, Chubut Province, U9000AKX, Argentina
GSK Investigational Site
Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
GSK Investigational Site
Godoy Cruz, Mendoza Province, MQ 5500, Argentina
GSK Investigational Site
San Rafael, Mendoza Province, M5602HWT, Argentina
GSK Investigational Site
Bariloche, Río Negro Province, R8401DKA, Argentina
GSK Investigational Site
Cipolletti, Río Negro Province, 8324, Argentina
GSK Investigational Site
El Calafate, Santa Cruz Province, Z9405CJM, Argentina
GSK Investigational Site
Buenos Aires, C1120AAC, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Corrientes, W3410AVV, Argentina
GSK Investigational Site
San Juan, 5400, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000DGF, Argentina
GSK Investigational Site
San Salvador de Jujuy, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Santa Fe, 3016, Argentina
GSK Investigational Site
Santa Fe, S3000AZG, Argentina
GSK Investigational Site
Bodø, 8005, Norway
GSK Investigational Site
Levanger, 7600, Norway
GSK Investigational Site
Stavanger, 4011, Norway
GSK Investigational Site
Trondheim, 7030, Norway
GSK Investigational Site
Tønsberg, 3116, Norway
GSK Investigational Site
Volda, 6100, Norway
Related Publications (1)
Ohar JA, Crater GD, Emmett A, Ferro TJ, Morris AN, Raphiou I, Sriram PS, Dransfield MT. Fluticasone propionate/salmeterol 250/50 mug versus salmeterol 50 mug after chronic obstructive pulmonary disease exacerbation. Respir Res. 2014 Sep 24;15(1):105. doi: 10.1186/s12931-014-0105-2.
PMID: 25248764DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 26, 2010
Study Start
April 30, 2010
Primary Completion
April 1, 2012
Study Completion
May 8, 2012
Last Updated
November 8, 2017
Results First Posted
January 18, 2013
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.