| Primary | Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal | The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. | All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis. | Posted | | Number | | percentage of participants | | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician |
| | | Title | Denominators | Categories |
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| <80% predicted normal | | | | >=80% predicted normal | | |
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| Secondary | Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal | The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. | All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis. | Posted | | Number | | percentage of participants | | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician |
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| Secondary | Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios | The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC). | All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis. | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician |
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| Secondary | Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% | The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). | All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted | Posted | | Mean | Standard Error | points on a scale | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80% |
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| Secondary | Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% | The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). | All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted | Posted | | Mean | Standard Error | points on a scale | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80% |
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| Secondary | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80% |
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| Secondary | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50% |
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| Secondary | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80% |
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| Secondary | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Number | | participants | | Day 1 of 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50% |
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| Secondary | Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Mean | Standard Error | puffs | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80% |
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| Secondary | Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Mean | Standard Error | puffs | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50% |
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| Secondary | 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 | The number of participants with the indicated affected medical conditions were counted. | All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure | Posted | | Number | | participants | | Day 1 of a 1-day study | | | | ID | Title | Description |
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| OG000 | Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80% | | OG001 | Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80% | | OG002 | Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50% |
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