Last updated: 11/03/2018 12:23:01
Evaluation of Lung Function and Symptoms in Patients Diagnosed with Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator MonotherapyLABD
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An Evaluation of Lung Function and Symptoms in Patients with Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
Trial description: A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants whose post-albuterol forced expiratory volume in one second (FEV1) was <80% predicted normal
Timeframe: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Secondary outcomes:
Percentage of participants whose post-albuterol FEV1 was <50% predicted normal
Timeframe: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Number of participants with the categorized post-albuterol forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratios
Timeframe: Day 1 of a 1-day study
Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for participants with post-albuterol FEV1 <80% and >=80%
Timeframe: Day 1 of a 1-day study
Mean mMRC Dyspnea Scale Scores for participants with post-albuterol FEV1 <50% and >=50%
Timeframe: Day 1 of a 1-day study
Number of participants who had a COPD exacerbation requiring hospitalization with post-albuterol FEV1 <80% and >=80%
Timeframe: Day 1 of a 1-day study
Number of participants who had a COPD exacerbation requiring hospitalization with post-albuterol FEV1 <50% and >=50%
Timeframe: Day 1 of 1-day study
Number of participants who had a COPD exacerbation requiring oral corticosteroids and/or antibiotics with post-albuterol FEV1 <80% and >=80%
Timeframe: Day 1 of 1-day study
Number of participants who had a COPD exacerbation requiring oral corticosteroids and/or antibiotics with post-albuterol FEV1 <50% and >=50%
Timeframe: Day 1 of 1-day study
Mean puffs from all short-acting bronchodilators used in the past two weeks in participants with an FEV1 of <80% and >=80%
Timeframe: Day 1 of a 1-day study
Mean number of puffs from all short-acting bronchodilators used in the past two weeks in participants with an FEV1 of <50% and >=50%
Timeframe: Day 1 of a 1-day study
Number of participants with reports of diagnosis and/or treatment for specific cardiovascular (heart), psychiatric (anxiety or depression), and/or bone disorders in the <80%, >=80%, <50%, and >=50% FEV1 groups
Timeframe: Day 1 of a 1-day study
Interventions:
Drug: No intervention
Enrollment:
1084
Observational study model:
Other
Primary completion date:
2009-01-05
Time perspective:
Prospective
Clinical publications:
Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011 Mar;20(1):46-53.
Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J.2010;20(1):46-53
Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B.Disease severity and symptoms among patients receiving monotherapy for COPD.Prim Care Respir J.2010;20(1):46-53
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
salbutamol, salmeterol
Collaborators
Not applicable
Study date(s)
December 2008 to May 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40 - 99 years
Accepts healthy volunteers
No
- Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
- Established history of COPD as diagnosed by a physician
- Currently active asthma (receiving asthma therapy and or having asthma symptoms)
- Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
Inclusion and exclusion criteria
Inclusion criteria:
- Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit) -Established history of COPD as diagnosed by a physician -Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit -Ability to read, comprehend, and record information in the English language
Exclusion criteria:
- Currently active asthma (receiving asthma therapy and or having asthma symptoms) -Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit -Previous lung surgery -Other respiratory disorders other than COPD -Current alcohol, illegal drug, or solvent abuse -Females with a positive urine pregnancy test at the study visit
Trial location(s)
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Naranja, Florida, United States, 33032
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 25249
Status
Study Complete
Location
GSK Investigational Site
New Tazewell, Tennessee, United States, 37824-1409
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76309
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46229
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55904
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Milan, Tennessee, United States, 38358
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29650
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
South Miami, Florida, United States, 33143
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12205
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Mooresville, North Carolina, United States, 28117
Status
Study Complete
Location
GSK Investigational Site
Clairton, Pennsylvania, United States, 15205
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Biddeford, Maine, United States, 04005
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47711
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2009-01-05
Actual study completion date
2009-01-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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