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
Study complete
Study complete
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:
Enrollment:
1084
Primary completion date:
2009-01-05
Observational study model:
Other
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
Showing 1 - 6 of 57 Results
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website