Trial Outcomes & Findings for Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy (NCT NCT00791518)

NCT ID: NCT00791518

Last Updated: 2014-07-30

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1084 participants
• Primary outcome timeframe: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
• Results posted on: 2014-07-30

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	1084
Overall Study COMPLETED	991
Overall Study NOT COMPLETED	93

Reasons for withdrawal

Measure	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
Overall Study Protocol Violation	93

Baseline Characteristics

Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Baseline characteristics by cohort

Measure	Participants With Diagnosed COPD n=1084 Participants 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
Age, Continuous	61.2 years STANDARD_DEVIATION 10.90 • n=5 Participants
Sex: Female, Male Female	537 Participants n=5 Participants
Sex: Female, Male Male	547 Participants n=5 Participants
Race/Ethnicity, Customized White	933 participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	146 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Japanese East Asian Heritage	1 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native and White	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants With Diagnosed COPD n=1072 Participants 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	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%	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%	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%
Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal <80% predicted normal	70 percentage of participants	—	—	—
Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal >=80% predicted normal	30 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants With Diagnosed COPD n=1072 Participants 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	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%	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%	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%
Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal <50% predicted normal	23 percentage of participants	—	—	—
Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal >=50% predicted normal	77 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Participants With Diagnosed COPD n=1072 Participants 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	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%	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%	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%
Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios <=0.70	689 participants	—	—	—
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 outcome

Timeframe: 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

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).

Outcome measures

Measure	Participants With Diagnosed COPD n=754 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=318 Participants 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%	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%	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%
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	1.6 points on a scale Standard Error 0.05	—	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Participants With Diagnosed COPD n=242 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=819 Participants 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%	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%	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%
Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%	1.9 points on a scale Standard Error 0.06	1.6 points on a scale Standard Error 0.03	—	—

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=754 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=318 Participants 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%	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%	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%
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%	41 participants	7 participants	—	—

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=244 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=828 Participants 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%	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%	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%
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%	16 participants	32 participants	—	—

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=754 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=318 Participants 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%	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%	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%
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%	246 participants	117 participants	—	—

SECONDARY outcome

Timeframe: Day 1 of 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=244 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=828 Participants 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%	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%	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%
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%	79 participants	284 participants	—	—

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=754 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=318 Participants 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%	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%	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%
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	2.3 puffs Standard Error 0.43	—	—

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.

Outcome measures

Measure	Participants With Diagnosed COPD n=244 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=828 Participants 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%	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%	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%
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	2.8 puffs Standard Error 0.28	—	—

SECONDARY outcome

Timeframe: Day 1 of a 1-day study

Population: All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure

The number of participants with the indicated affected medical conditions were counted.

Outcome measures

Measure	Participants With Diagnosed COPD n=754 Participants 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	Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% n=318 Participants 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%	Participants With Diagnosed COPD and Post-albuterol FEV1 <50% n=244 Participants 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%	Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% n=828 Participants 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%
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	7 participants	13 participants	19 participants
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	1 participants	3 participants	6 participants
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	1 participants	0 participants	3 participants
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	2 participants	0 participants	2 participants
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	134 participants	123 participants	400 participants
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	24 participants	26 participants	85 participants
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	9 participants	23 participants	55 participants
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	11 participants	20 participants	41 participants
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	16 participants	16 participants	40 participants
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	7 participants	10 participants	23 participants
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	9 participants	6 participants	25 participants
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	7 participants	6 participants	19 participants
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	4 participants	6 participants	9 participants
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	2 participants	5 participants	7 participants
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	3 participants	4 participants	7 participants
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	0 participants	5 participants	6 participants
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	3 participants	1 participants	7 participants
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	2 participants	1 participants	6 participants
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	0 participants	2 participants	3 participants
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	1 participants	2 participants	3 participants
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	3 participants	0 participants	4 participants
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	1 participants	1 participants	1 participants
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	0 participants	0 participants	2 participants
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	38 participants	37 participants	114 participants
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	45 participants	30 participants	122 participants
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	17 participants	7 participants	34 participants
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	12 participants	7 participants	29 participants
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	6 participants	4 participants	19 participants
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	8 participants	4 participants	18 participants
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	4 participants	4 participants	9 participants
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	26 participants	29 participants	89 participants
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	10 participants	11 participants	31 participants

Adverse Events

Participants With Diagnosed COPD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants With Diagnosed COPD n=1084 participants at risk 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
Injury, poisoning and procedural complications Tooth fracture	0.09% 1/1084 • Day 1 of a 1-day study
Metabolism and nutrition disorders Hypoglycemia	0.09% 1/1084 • Day 1 of a 1-day study
Nervous system disorders Tremor	0.09% 1/1084 • Day 1 of a 1-day study
Skin and subcutaneous tissue disorders Petechiae	0.09% 1/1084 • Day 1 of a 1-day study
Vascular disorders Hypertension	0.09% 1/1084 • Day 1 of a 1-day study

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER