Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Spirometry
Brief summary
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.
Interventions
DRUGNo intervention
No intervention
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | 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. |
| Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios | Day 1 of a 1-day study | 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). |
| Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% | Day 1 of a 1-day study | 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). |
| Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% | Day 1 of a 1-day study | 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). |
| Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% | Day 1 of a 1-day study | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. |
| 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 | Day 1 of a 1-day study | The number of participants with the indicated affected medical conditions were counted. |
| Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% | Day 1 of 1-day study | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. |
| Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% | Day 1 of 1-day study | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. |
| Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% | Day 1 of a 1-day study | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. |
| Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% | Day 1 of a 1-day study | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. |
| Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% | Day 1 of 1-day study | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,084 |
| Total | 1,084 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 93 |
Baseline characteristics
| Characteristic | Participants With Diagnosed COPD |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10.9 |
| Race/Ethnicity, Customized African American/African Heritage | 146 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native and White | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Japanese East Asian Heritage | 1 participants |
| Race/Ethnicity, Customized White | 933 participants |
| Sex: Female, Male Female | 537 Participants |
| Sex: Female, Male Male | 547 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 1,084 |
| serious Total, serious adverse events | 0 / 1,084 |
Outcome results
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.
Time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Diagnosed COPD | Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal | >=80% predicted normal | 30 percentage of participants |
| Participants With Diagnosed COPD | Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal | <80% predicted normal | 70 percentage of participants |
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).
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 \<50% and \>=50% predicted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Diagnosed COPD | Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% | 1.9 points on a scale | Standard Error 0.06 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% | 1.6 points on a scale | Standard Error 0.03 |
95% CI: [0.2, 0.4]
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).
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 \<80% and \>=80% percent predicted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Diagnosed COPD | Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% | 1.7 points on a scale | Standard Error 0.04 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% | 1.6 points on a scale | Standard Error 0.05 |
95% CI: [0.1, 0.4]
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.
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Diagnosed COPD | Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% | 5.2 puffs | Standard Error 0.66 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% | 2.8 puffs | Standard Error 0.28 |
95% CI: [-0.2, 2.1]
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.
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Diagnosed COPD | Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% | 3.8 puffs | Standard Error 0.33 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% | 2.3 puffs | Standard Error 0.43 |
95% CI: [-0.4, 1.7]
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.
Time frame: Day 1 of 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Diagnosed COPD | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% | 16 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% | 32 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Diagnosed COPD | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% | 41 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% | 7 participants |
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.
Time frame: Day 1 of 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Diagnosed COPD | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% | 79 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% | 284 participants |
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.
Time frame: Day 1 of 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Diagnosed COPD | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% | 246 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% | 117 participants |
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.
Time frame: Day 1 of a 1-day study
Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Diagnosed COPD | 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 | Ischemic heart disease without cardiomyopathy | 10 participants |
| Participants With Diagnosed COPD | 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 | Heart failure | 26 participants |
| Participants With Diagnosed COPD | 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 | Cerebrovascular disease | 5 participants |
| Participants With Diagnosed COPD | 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 | Transient ischemic attack | 0 participants |
| Participants With Diagnosed COPD | 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 | Valvular heart disease | 18 participants |
| Participants With Diagnosed COPD | 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 | Atherosclerosis | 50 participants |
| Participants With Diagnosed COPD | 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 | Left ventricular hypertrophy | 4 participants |
| Participants With Diagnosed COPD | 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 | Stroke | 1 participants |
| Participants With Diagnosed COPD | 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 | Generalized anxiety disorder | 113 participants |
| Participants With Diagnosed COPD | 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 | Major depressive disorder, single episode | 17 participants |
| Participants With Diagnosed COPD | 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 | Unstable angina | 2 participants |
| Participants With Diagnosed COPD | 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 | Myocardial infarction | 1 participants |
| Participants With Diagnosed COPD | 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 | Peripheral vascular disease | 22 participants |
| Participants With Diagnosed COPD | 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 | Stable angina | 25 participants |
| Participants With Diagnosed COPD | 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 | Arrhythmia | 40 participants |
| Participants With Diagnosed COPD | 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 | Coronary artery disease | 87 participants |
| Participants With Diagnosed COPD | 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 | Cardiac arrest | 2 participants |
| Participants With Diagnosed COPD | 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 | Diastolic dysfunction | 5 participants |
| Participants With Diagnosed COPD | 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 | Post-traumatic stress disorder | 14 participants |
| Participants With Diagnosed COPD | 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 | Ischemic heart disease with cardiomyopathy | 11 participants |
| Participants With Diagnosed COPD | 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 | Attention deficit/hyperactivity disorder | 9 participants |
| Participants With Diagnosed COPD | 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 | Social anxiety disorder (social phobia) | 24 participants |
| Participants With Diagnosed COPD | 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 | Left ventricular dysfunction | 5 participants |
| Participants With Diagnosed COPD | 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 | Edema | 69 participants |
| Participants With Diagnosed COPD | 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 | Osteoporosis | 92 participants |
| Participants With Diagnosed COPD | 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 | Panic disorder | 24 participants |
| Participants With Diagnosed COPD | 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 | Cardiomyopathy | 8 participants |
| Participants With Diagnosed COPD | 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 | Cardiomegaly | 8 participants |
| Participants With Diagnosed COPD | 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 | Osteopenia | 32 participants |
| Participants With Diagnosed COPD | 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 | Major depressive disorder, recurrent episode | 107 participants |
| Participants With Diagnosed COPD | 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 | Pulmonary edema | 11 participants |
| Participants With Diagnosed COPD | 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 | Hypertension | 389 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Peripheral vascular disease | 9 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Generalized anxiety disorder | 38 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Major depressive disorder, recurrent episode | 45 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Social anxiety disorder (social phobia) | 17 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Panic disorder | 12 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Ischemic heart disease with cardiomyopathy | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Major depressive disorder, single episode | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Post-traumatic stress disorder | 8 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Attention deficit/hyperactivity disorder | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Hypertension | 134 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Osteoporosis | 26 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Osteopenia | 10 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Cardiomegaly | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Cerebrovascular disease | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Atherosclerosis | 11 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Unstable angina | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Edema | 9 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Arrhythmia | 16 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Stable angina | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Coronary artery disease | 24 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Valvular heart disease | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Heart failure | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Cardiomyopathy | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Left ventricular dysfunction | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Diastolic dysfunction | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Pulmonary edema | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Left ventricular hypertrophy | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Stroke | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Cardiac arrest | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Myocardial infarction | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Ischemic heart disease without cardiomyopathy | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 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 | Transient ischemic attack | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Cardiomegaly | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Osteopenia | 11 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Ischemic heart disease without cardiomyopathy | 5 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Major depressive disorder, single episode | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Osteoporosis | 29 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Cardiomyopathy | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Peripheral vascular disease | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Attention deficit/hyperactivity disorder | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Cardiac arrest | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Left ventricular dysfunction | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Coronary artery disease | 26 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Ischemic heart disease with cardiomyopathy | 5 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Panic disorder | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Diastolic dysfunction | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Major depressive disorder, recurrent episode | 30 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Generalized anxiety disorder | 37 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Post-traumatic stress disorder | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Left ventricular hypertrophy | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Edema | 23 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Atherosclerosis | 20 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Pulmonary edema | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Heart failure | 10 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Arrhythmia | 16 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Social anxiety disorder (social phobia) | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Myocardial infarction | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Stable angina | 13 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Stroke | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Unstable angina | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Transient ischemic attack | 0 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Cerebrovascular disease | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Hypertension | 123 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 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 | Valvular heart disease | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Osteopenia | 31 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Hypertension | 400 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Coronary artery disease | 85 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Edema | 55 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Atherosclerosis | 41 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Arrhythmia | 40 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Peripheral vascular disease | 25 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Pulmonary edema | 9 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Cardiomyopathy | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Ischemic heart disease with cardiomyopathy | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Cerebrovascular disease | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Transient ischemic attack | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Social anxiety disorder (social phobia) | 34 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Post-traumatic stress disorder | 18 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Heart failure | 23 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Stable angina | 19 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Valvular heart disease | 19 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Ischemic heart disease without cardiomyopathy | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Cardiomegaly | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Left ventricular dysfunction | 7 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Diastolic dysfunction | 6 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Left ventricular hypertrophy | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Stroke | 4 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Cardiac arrest | 3 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Myocardial infarction | 1 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Unstable angina | 2 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Generalized anxiety disorder | 114 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Major depressive disorder, recurrent episode | 122 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Panic disorder | 29 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Major depressive disorder, single episode | 19 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Attention deficit/hyperactivity disorder | 9 participants |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 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 | Osteoporosis | 89 participants |
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).
Time frame: Day 1 of a 1-day study
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Diagnosed COPD | Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios | <=0.70 | 689 participants |
| Participants With Diagnosed COPD | Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios | >0.70 | 383 participants |
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.
Time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Diagnosed COPD | Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal | <50% predicted normal | 23 percentage of participants |
| Participants With Diagnosed COPD | Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal | >=50% predicted normal | 77 percentage of participants |