Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
Interventions
DRUGtiotropium
Oral inhalation once daily of 18mcg tiotropium via handihaler
DRUGPlacebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Sponsors
Pfizer
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria: post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years. Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.
Exclusion criteria
Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) | baseline, week 24 | Change = Week 24 Value - Baseline Value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) | baseline, week 8, 120 minutes | Change from baseline in forced vital capacity (week 8, 120 minutes) |
| Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) | Baseline | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) | Baseline, week 8 | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) | Baseline, week 16 | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) | Baseline, week 24 | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Peak Forced Expiratory Volume in 1 Second (Baseline) | Baseline | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) | Baseline, week 8 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) | Baseline, week 16 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) | Baseline, week 24 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) | Baseline | Forced expiratory volume in 1 second (baseline, pre-dose) |
| Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) | baseline, 30 minutes | Forced expiratory volume in 1 second (baseline, 30 minutes) |
| Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) | baseline, 60 minutes | Forced expiratory volume in 1 second (baseline, 60 minutes) |
| Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) | Baseline, 120 minutes | Forced expiratory volume in 1 second (baseline, 120 minutes) |
| Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) | Baseline, 180 minutes | Forced expiratory volume in 1 second (baseline, 180 minutes) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) | baseline, week 8, pre-dose | Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) | Baseline, week 8, 30 minutes | Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) | baseline, week 8, 60 minutes | Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) | baseline, week 8, 120 minutes | Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) | baseline, week 8, 180 minutes | Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes) |
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) | baseline, week 16, pre-dose | Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) | Baseline, week 16, 30 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) | baseline, week 16, 60 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) | baseline, week 16, 120 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) | baseline, week 16, 180 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) | baseline, week 24, pre-dose | Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) | baseline, week 24, 30 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) | baseline, week 24, 60 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) | baseline, week 24, 120 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes) |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) | baseline, week 24, 180 minutes | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes) |
| FVC AUC0-3 at Baseline | baseline | Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) |
| FVC AUC0-3 at Week 8 Minus Baseline | baseline, week 8 | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8) |
| FVC AUC0-3 at Week 16 Minus Baseline | baseline, week 16 | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16) |
| FVC AUC0-3 at Week 24 Minus Baseline | baseline, week 24 | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24) |
| Trough Forced Vital Capacity (Baseline) | baseline | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Trough Forced Vital Capacity (at Week 8) | baseline, week 8 | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Trough Forced Vital Capacity (at Week 16) | baseline, week 16 | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) | baseline, week 8, 180 minutes | Change from baseline in forced vital capacity (week 8, 180 minutes) |
| Change From Baseline in Trough Forced Vital Capacity (at Week 24) | baseline, week 24 | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. |
| Peak Forced Vital Capacity (FVC) (Baseline) | baseline | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. |
| Change From Baseline in Peak Forced Vital Capacity (at Week 8) | baseline, week 8 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Change From Baseline in Peak Forced Vital Capacity (at Week 16) | baseline, week 16 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Change From Baseline in Peak Forced Vital Capacity (at Week 24) | baseline, week 24 | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. |
| Forced Vital Capacity (Baseline, Pre-dose) | baseline | Forced vital capacity (baseline, pre-dose) |
| Forced Vital Capacity (Baseline, 30 Minutes) | baseline, 30 minutes | Forced vital capacity (baseline, 30 minutes) |
| Forced Vital Capacity (Baseline, 60 Minutes) | baseline, 60 minutes | Forced vital capacity (baseline, 60 minutes) |
| Forced Vital Capacity (Baseline, 120 Minutes) | baseline, 120 minutes | Forced vital capacity (baseline, 120 minutes) |
| Forced Vital Capacity (Baseline, 180 Minutes) | baseline, 180 minutes | Forced vital capacity (baseline, 180 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) | baseline, week 8, pre-dose | Change from baseline in forced vital capacity (week 8, pre-dose) |
| Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) | baseline, week 8, 30 minutes | Change from baseline in forced vital capacity (week 8, 30 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) | baseline, week 16, pre-dose | Change from baseline in forced vital capacity (week 16, pre-dose) |
| Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) | baseline, week 16, 30 minutes | Change from baseline in forced vital capacity (week 16, 30 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) | baseline, week 16, 60 minutes | Change from baseline in forced vital capacity (week 16, 60 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) | baseline, week 16, 120 minutes | Change from baseline in forced vital capacity (week 16, 120 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) | baseline, week 16, 180 minutes | Change from baseline in forced vital capacity (week 16, 180 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) | baseline, week 24, pre-dose | Change from baseline in forced vital capacity (week 24, pre-dose) |
| Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) | baseline, week 24, 30 minutes | Change from baseline in forced vital capacity (week 24, 30 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) | baseline, week 24, 60 minutes | Change from baseline in forced vital capacity (week 24, 60 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) | baseline, week 24, 120 minutes | Change from baseline in forced vital capacity (week 24, 120 minutes) |
| Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) | baseline, week 24, 180 minutes | Change from baseline in forced vital capacity (week 24, 180 minutes) |
| Albuterol Use p.r.n. (Baseline) | baseline | Number of days that participants used albuterol prn per week |
| Change From Baseline in Albuterol Use p.r.n. - (Week 4) | baseline, week 4 | Difference in number of days that participants used albuterol prn per week between week 4 and baseline |
| Change From Baseline in Albuterol Use p.r.n. - (Week 8) | baseline, week 8 | Difference in number of days that participants used albuterol prn per week between week 8 and baseline |
| Change From Baseline in Albuterol Use p.r.n. -(Week 12) | baseline, week 12 | Difference in number of days that participants used albuterol prn per week between week 12 and baseline |
| Change From Baseline in Albuterol Use p.r.n. - (Week 16) | baseline, week 16 | Difference in number of days that participants used albuterol prn per week between week 16 and baseline |
| Change From Baseline in Albuterol Use p.r.n. -(Week 20) | baseline, week 20 | Difference in number of days that participants used albuterol prn per week between week 20 and baseline |
| Change From Baseline in Albuterol Use p.r.n. - (Week 24) | baseline, week 24 | Difference in number of days that participants used albuterol prn per week between week 24 and baseline |
| Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | baseline | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | week 12 | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | week 24 | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | baseline | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | week 12 | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | week 24 | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. |
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) | baseline | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) | baseline, week 4 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) | baseline, week 8 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) | baseline, week 12 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) | baseline, week 16 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) | baseline, week 20 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) | baseline, week 24 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. |
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health | baseline | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) | baseline, week 4 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) | baseline, week 8 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) | baseline, week 12 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) | baseline, week 16 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) | baseline, week 20 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) | baseline, week 24 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. |
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) | baseline | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) | baseline, week 4 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) | baseline, week 8 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) | baseline, week 12 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) | baseline, week 16 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) | baseline, week 20 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) | baseline, week 24 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. |
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) | baseline | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) | baseline, week 4 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) | baseline, week 8 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) | baseline, week 12 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) | baseline, week 16 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) | baseline, week 20 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. |
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) | baseline, week 24 | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. |
| Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | baseline | Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm. |
| Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 4 | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 8 | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 12 | Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 16 | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 20 | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 24 | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | baseline | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 4 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 8 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 12 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Number of Participants With Healthy Lifestyle (Week 16) | week 16 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Number of Participants With Healthy Lifestyle (Week 20) | week 20 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 16 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 20 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | baseline, week 24 | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm |
| Number of Participants With Healthy Lifestyle (Baseline) | baseline | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Number of Participants With Healthy Lifestyle (Week 4) | week 4 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) | baseline, week 8, 60 minutes | Change from baseline in forced vital capacity (week 8, 60 minutes) |
| Number of Participants With Healthy Lifestyle (Week 12) | week 12 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Number of Participants With Healthy Lifestyle (Week 24) | week 24 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
| Active Energy Expenditure (Baseline) | baseline | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 4) | baseline, week 4 | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 8) | baseline, week 8 | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 12) | baseline, week 12 | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 16) | baseline, week 16 | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 20) | baseline, week 20 | The amount of energy (kcal/day) that a person uses while physically active. |
| Change From Baseline in Active Energy Expenditure (Week 24) | baseline, week 24 | The amount of energy (kcal/day) that a person uses while physically active. |
| Number of Steps Per Day (Baseline) | baseline | Number of steps per day (baseline) |
| Change From Baseline in Number of Steps Per Day (Week 4) | baseline, week 4 | Change from baseline in number of steps per day (week 4) |
| Change From Baseline in Number of Steps Per Day(Week 8) | baseline, week 8 | Change from baseline in number of steps per day (week 8) |
| Change From Baseline in Number of Steps Per Day (Week 12) | baseline, week 12 | Change from baseline in Number of steps per day (week 12) |
| Change From Baseline in Number of Steps Per Day (Week 16) | baseline, week 16 | Change from baseline in number of steps per day (week 16) |
| Change From Baseline in Number of Steps Per Day (Week 20) | baseline, week 20 | Change from baseline in number of steps per day (week 20) |
| Change From Baseline in Number of Steps Per Day (Week 24) | baseline, week 24 | Change from baseline in number of steps per day (week 24) |
| Number of Participants With Healthy Lifestyle (Week 8) | week 8 | Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no |
Countries
Belgium, Canada, Czechia, Germany, Greece, Netherlands, Portugal, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matching tiotropium via HandiHaler® + PRN albuterol | 219 |
| Tiotropium 18 mcg tiotropium via HandiHaler® + PRN albuterol | 238 |
| Total | 457 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 5 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Other reason (not specified) | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 17 |
Baseline characteristics
| Characteristic | Placebo | Tiotropium | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 8.6 | 61.2 years STANDARD_DEVIATION 8.2 | 61.7 years STANDARD_DEVIATION 8.4 |
| Age, Customized 18-44 years | 8 participants | 7 participants | 15 participants |
| Age, Customized 45-64 years | 121 participants | 151 participants | 272 participants |
| Age, Customized >=65 years | 90 participants | 80 participants | 170 participants |
| Race/Ethnicity, Customized Black | 6 participants | 4 participants | 10 participants |
| Race/Ethnicity, Customized White | 213 participants | 234 participants | 447 participants |
| Sex: Female, Male Female | 72 Participants | 72 Participants | 144 Participants |
| Sex: Female, Male Male | 147 Participants | 166 Participants | 313 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 219 | 26 / 238 |
| serious Total, serious adverse events | 11 / 219 | 10 / 238 |
Outcome results
Primary
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Change = Week 24 Value - Baseline Value
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) | -0.06 litres * hours | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) | 0.16 litres * hours | Standard Error 0.02 |
p-value: <0.00195% CI: [0.18, 0.27]ANCOVA
Secondary
Active Energy Expenditure (Baseline)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Active Energy Expenditure (Baseline) | 0.87 kilo calories per day | Standard Deviation 0.46 |
| Tiotropium | Active Energy Expenditure (Baseline) | 0.87 kilo calories per day | Standard Deviation 0.46 |
Secondary
Albuterol Use p.r.n. (Baseline)
Number of days that participants used albuterol prn per week
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Albuterol Use p.r.n. (Baseline) | 2.1 days | Standard Deviation 2.76 |
| Tiotropium | Albuterol Use p.r.n. (Baseline) | 1.8 days | Standard Deviation 2.63 |
Secondary
Change From Baseline in Active Energy Expenditure (Week 12)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 12
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 12) | -0.05 kilo calories per day | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 12) | -0.06 kilo calories per day | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: 0.6795% CI: [-0.08, 0.05]ANCOVA
Secondary
Change From Baseline in Active Energy Expenditure (Week 16)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 16
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 16) | -0.07 kilo calories per day | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 16) | -0.09 kilo calories per day | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: 0.6395% CI: [-0.09, 0.06]ANCOVA
Secondary
Change From Baseline in Active Energy Expenditure (Week 20)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 20
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 20) | -0.08 kilo calories per day | Standard Error 0.04 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 20) | -0.09 kilo calories per day | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: 0.70495% CI: [-0.1, 0.07]ANCOVA
Secondary
Change From Baseline in Active Energy Expenditure (Week 24)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 24
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 24) | -0.08 kilo calories per day | Standard Error 0.04 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 24) | -0.10 kilo calories per day | Standard Error 0.04 |
Comparison: tiotropium versus placebop-value: 0.57995% CI: [-0.11, 0.06]ANCOVA
Secondary
Change From Baseline in Active Energy Expenditure (Week 4)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 4
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 4) | -0.04 kilo calories per day | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 4) | -0.03 kilo calories per day | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: 0.81995% CI: [-0.05, 0.06]ANCOVA
Secondary
Change From Baseline in Active Energy Expenditure (Week 8)
The amount of energy (kcal/day) that a person uses while physically active.
Time frame: baseline, week 8
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Active Energy Expenditure (Week 8) | 0.01 kilo calories per day | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Active Energy Expenditure (Week 8) | -0.03 kilo calories per day | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: 0.20495% CI: [-0.1, 0.02]ANCOVA
Secondary
Change From Baseline in Albuterol Use p.r.n. -(Week 12)
Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Time frame: baseline, week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. -(Week 12) | -0.3 days | Standard Deviation 2.16 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. -(Week 12) | -0.3 days | Standard Deviation 2.09 |
Secondary
Change From Baseline in Albuterol Use p.r.n. - (Week 16)
Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. - (Week 16) | -0.4 days | Standard Deviation 2.1 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. - (Week 16) | -0.3 days | Standard Deviation 2.26 |
Secondary
Change From Baseline in Albuterol Use p.r.n. -(Week 20)
Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Time frame: baseline, week 20
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. -(Week 20) | -0.4 days | Standard Deviation 2.34 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. -(Week 20) | -0.3 days | Standard Deviation 2.21 |
Secondary
Change From Baseline in Albuterol Use p.r.n. - (Week 24)
Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. - (Week 24) | -0.64 days | Standard Error 0.18 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. - (Week 24) | -0.62 days | Standard Error 0.17 |
Comparison: tiotropium versus placebop-value: 0.92795% CI: [-0.38, 0.41]ANCOVA
Secondary
Change From Baseline in Albuterol Use p.r.n. - (Week 4)
Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Time frame: baseline, week 4
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. - (Week 4) | -0.2 days | Standard Deviation 1.71 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. - (Week 4) | -0.2 days | Standard Deviation 2.07 |
Secondary
Change From Baseline in Albuterol Use p.r.n. - (Week 8)
Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Albuterol Use p.r.n. - (Week 8) | -0.3 days | Standard Deviation 2.13 |
| Tiotropium | Change From Baseline in Albuterol Use p.r.n. - (Week 8) | -0.3 days | Standard Deviation 1.96 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Time frame: baseline, week 16, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) | -0.06 litres | Standard Deviation 0.21 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) | 0.09 litres | Standard Deviation 0.27 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Time frame: baseline, week 8, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) | 0.01 litres | Standard Deviation 0.23 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) | 0.24 litres | Standard Deviation 0.23 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Time frame: baseline, week 8, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) | 0.01 litres | Standard Deviation 0.22 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) | 0.24 litres | Standard Deviation 0.25 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Time frame: Baseline, week 8, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) | 0.00 litres | Standard Deviation 0.22 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) | 0.20 litres | Standard Deviation 0.22 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Time frame: baseline, week 8, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) | 0.01 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) | 0.22 litres | Standard Deviation 0.24 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Time frame: baseline, week 8, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) | -0.03 litres | Standard Deviation 0.21 |
| Tiotropium | Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) | 0.12 litres | Standard Deviation 0.21 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
Change from baseline in forced vital capacity (week 16, 120 minutes)
Time frame: baseline, week 16, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) | -0.05 litres | Standard Deviation 0.41 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) | 0.26 litres | Standard Deviation 0.45 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
Change from baseline in forced vital capacity (week 16, 180 minutes)
Time frame: baseline, week 16, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) | -0.05 litres | Standard Deviation 0.42 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) | 0.26 litres | Standard Deviation 0.45 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
Change from baseline in forced vital capacity (week 16, 30 minutes)
Time frame: baseline, week 16, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) | -0.06 litres | Standard Deviation 0.39 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) | 0.24 litres | Standard Deviation 0.45 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
Change from baseline in forced vital capacity (week 16, 60 minutes)
Time frame: baseline, week 16, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) | -0.05 litres | Standard Deviation 0.41 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) | 0.27 litres | Standard Deviation 0.45 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
Change from baseline in forced vital capacity (week 16, pre-dose)
Time frame: baseline, week 16, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) | -0.13 litres | Standard Deviation 0.37 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) | 0.10 litres | Standard Deviation 0.42 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
Change from baseline in forced vital capacity (week 24, 120 minutes)
Time frame: baseline, week 24, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) | -0.11 litres | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) | 0.22 litres | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.25, 0.4]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
Change from baseline in forced vital capacity (week 24, 180 minutes)
Time frame: baseline, week 24, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) | -0.07 litres | Standard Error 0.04 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) | 0.29 litres | Standard Error 0.04 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.26, 0.45]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
Change from baseline in forced vital capacity (week 24, 30 minutes)
Time frame: baseline, week 24, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) | -0.10 litres | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) | 0.19 litres | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.21, 0.36]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
Change from baseline in forced vital capacity (week 24, 60 minutes)
Time frame: baseline, week 24, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) | -0.07 litres | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) | 0.23 litres | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.23, 0.38]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
Change from baseline in forced vital capacity (week 24, pre-dose)
Time frame: baseline, week 24, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) | -0.14 litres | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) | 0.07 litres | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.14, 0.28]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
Change from baseline in forced vital capacity (week 8, 120 minutes)
Time frame: baseline, week 8, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) | -0.02 litres | Standard Deviation 0.39 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) | 0.30 litres | Standard Deviation 0.4 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
Change from baseline in forced vital capacity (week 8, 180 minutes)
Time frame: baseline, week 8, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) | 0.00 litres | Standard Deviation 0.37 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) | 0.30 litres | Standard Deviation 0.43 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
Change from baseline in forced vital capacity (week 8, 30 minutes)
Time frame: baseline, week 8, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) | 0.00 litres | Standard Deviation 0.35 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) | 0.27 litres | Standard Deviation 0.4 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
Change from baseline in forced vital capacity (week 8, 60 minutes)
Time frame: baseline, week 8, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) | 0.00 litres | Standard Deviation 0.37 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) | 0.29 litres | Standard Deviation 0.43 |
Secondary
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
Change from baseline in forced vital capacity (week 8, pre-dose)
Time frame: baseline, week 8, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) | -0.06 litres | Standard Deviation 0.33 |
| Tiotropium | Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) | 0.16 litres | Standard Deviation 0.38 |
Secondary
Change From Baseline in Number of Steps Per Day (Week 12)
Change from baseline in Number of steps per day (week 12)
Time frame: baseline, week 12
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day (Week 12) | -351.30 Steps | Standard Error 239.39 |
| Tiotropium | Change From Baseline in Number of Steps Per Day (Week 12) | -169.31 Steps | Standard Error 221.09 |
Comparison: placebo versus tiotropiump-value: 0.49595% CI: [-341.75, 705.73]ANCOVA
Secondary
Change From Baseline in Number of Steps Per Day (Week 16)
Change from baseline in number of steps per day (week 16)
Time frame: baseline, week 16
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day (Week 16) | -655.04 Steps | Standard Error 231.9 |
| Tiotropium | Change From Baseline in Number of Steps Per Day (Week 16) | -396.21 Steps | Standard Error 217.31 |
Comparison: tiotropium versus placebop-value: 0.31895% CI: [-250.37, 768.03]ANCOVA
Secondary
Change From Baseline in Number of Steps Per Day (Week 20)
Change from baseline in number of steps per day (week 20)
Time frame: baseline, week 20
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day (Week 20) | -408.34 Steps | Standard Error 247.32 |
| Tiotropium | Change From Baseline in Number of Steps Per Day (Week 20) | -197.17 Steps | Standard Error 232.96 |
Comparison: tiotropium versus placebop-value: 0.4595% CI: [-338.04, 760.39]ANCOVA
Secondary
Change From Baseline in Number of Steps Per Day (Week 24)
Change from baseline in number of steps per day (week 24)
Time frame: baseline, week 24
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day (Week 24) | -234.80 Steps | Standard Error 261.49 |
| Tiotropium | Change From Baseline in Number of Steps Per Day (Week 24) | -183.34 Steps | Standard Error 232.69 |
Comparison: tiotropium versus placebop-value: 0.85895% CI: [-512.2, 615.12]ANCOVA
Secondary
Change From Baseline in Number of Steps Per Day (Week 4)
Change from baseline in number of steps per day (week 4)
Time frame: baseline, week 4
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day (Week 4) | -263.91 Steps | Standard Error 203.37 |
| Tiotropium | Change From Baseline in Number of Steps Per Day (Week 4) | -287.45 Steps | Standard Error 189.24 |
Comparison: tiotropium versus placebop-value: 0.91695% CI: [-464.02, 416.94]ANCOVA
Secondary
Change From Baseline in Number of Steps Per Day(Week 8)
Change from baseline in number of steps per day (week 8)
Time frame: baseline, week 8
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Steps Per Day(Week 8) | -121.66 Steps | Standard Error 214.73 |
| Tiotropium | Change From Baseline in Number of Steps Per Day(Week 8) | -153.09 Steps | Standard Error 203.84 |
Comparison: tiotropium versus placebop-value: 0.89995% CI: [-520.19, 457.34]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: Baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) | 0.05 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) | 0.29 litres | Standard Deviation 0.28 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Time frame: baseline, week 16, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) | -0.03 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) | 0.22 litres | Standard Deviation 0.28 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Time frame: baseline, week 16, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) | -0.02 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) | 0.22 litres | Standard Deviation 0.28 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Time frame: Baseline, week 16, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) | -0.02 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) | 0.19 litres | Standard Deviation 0.27 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Time frame: baseline, week 16, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) | -0.02 litres | Standard Deviation 0.24 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) | 0.21 litres | Standard Deviation 0.27 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: Baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) | 0.02 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) | 0.26 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.19, 0.29]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Time frame: baseline, week 24, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) | -0.06 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) | 0.18 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.2, 0.29]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
Time frame: baseline, week 24, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) | -0.05 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) | 0.20 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.2, 0.3]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Time frame: baseline, week 24, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) | -0.05 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) | 0.15 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.16, 0.25]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Time frame: baseline, week 24, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) | -0.05 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) | 0.18 litres | Standard Error 0.02 |
Comparison: tiotropium vesus placebop-value: <0.00195% CI: [0.18, 0.28]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Time frame: baseline, week 24, pre-dose
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) | -0.08 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) | 0.06 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.09, 0.18]ANCOVA
Secondary
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: Baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) | 0.09 litres | Standard Deviation 0.22 |
| Tiotropium | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) | 0.31 litres | Standard Deviation 0.24 |
Secondary
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Vital Capacity (at Week 16) | 0.08 litres | Standard Deviation 0.4 |
| Tiotropium | Change From Baseline in Peak Forced Vital Capacity (at Week 16) | 0.38 litres | Standard Deviation 0.44 |
Secondary
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Vital Capacity (at Week 24) | 0.06 litres | Standard Error 0.04 |
| Tiotropium | Change From Baseline in Peak Forced Vital Capacity (at Week 24) | 0.40 litres | Standard Error 0.04 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.24, 0.42]ANCOVA
Secondary
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Vital Capacity (at Week 8) | 0.13 litres | Standard Deviation 0.34 |
| Tiotropium | Change From Baseline in Peak Forced Vital Capacity (at Week 8) | 0.43 litres | Standard Deviation 0.4 |
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 12
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | 0.02 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.6195% CI: [-0.03, 0.02]ANCOVA
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 16
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | 0.04 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.55495% CI: [-0.02, 0.04]ANCOVA
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 20
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | 0.04 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.54995% CI: [-0.02, 0.04]ANCOVA
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 24
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | 0.02 ln(minutes) | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.56895% CI: [-0.02, 0.04]ANCOVA
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 4
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | 0.02 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.66895% CI: [-0.03, 0.02]ANCOVA
Secondary
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 8
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | 0.02 ln(minutes) | Standard Error 0.01 |
| Tiotropium | Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | 0.03 ln(minutes) | Standard Error 0.01 |
Comparison: tiotropium versus placebop-value: 0.7895% CI: [-0.02, 0.03]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 12
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | -0.14 ln(minutes) | Standard Error 0.07 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | -0.09 ln(minutes) | Standard Error 0.06 |
Comparison: tiotropium versus placebop-value: 0.51895% CI: [-0.1, 0.19]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 16
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | -0.26 ln(minutes) | Standard Error 0.07 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | -0.20 ln(minutes) | Standard Error 0.06 |
Comparison: tiotropium versus placebop-value: 0.45595% CI: [-0.09, 0.21]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 20
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | -0.20 ln(minutes) | Standard Error 0.07 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | -0.20 ln(minutes) | Standard Error 0.07 |
Comparison: tiotropium versus placebop-value: 0.92795% CI: [-0.16, 0.15]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 24
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | -0.19 ln(minutes) | Standard Error 0.08 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | -0.20 ln(minutes) | Standard Error 0.07 |
Comparison: tiotropium versus placebop-value: 0.93395% CI: [-0.17, 0.16]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 4
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | -0.06 ln(minutes) | Standard Error 0.06 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | -0.12 ln(minutes) | Standard Error 0.05 |
Comparison: tiotropium versus placebop-value: 0.35895% CI: [-0.18, 0.07]ANCOVA
Secondary
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline, week 8
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | 0.01 ln(minutes) | Standard Error 0.05 |
| Tiotropium | Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | -0.06 ln(minutes) | Standard Error 0.05 |
Comparison: tiotropium versus placebop-value: 0.21995% CI: [-0.2, 0.05]ANCOVA
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: Baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) | -0.06 litres | Standard Deviation 0.21 |
| Tiotropium | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) | 0.09 litres | Standard Deviation 0.27 |
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: Baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) | -0.08 litres | Standard Error 0.02 |
| Tiotropium | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) | 0.06 litres | Standard Error 0.02 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.09, 0.18]ANCOVA
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: Baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) | -0.03 litres | Standard Deviation 0.21 |
| Tiotropium | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) | 0.12 litres | Standard Deviation 0.21 |
Secondary
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Vital Capacity (at Week 16) | -0.13 litres | Standard Deviation 0.37 |
| Tiotropium | Change From Baseline in Trough Forced Vital Capacity (at Week 16) | 0.10 litres | Standard Deviation 0.42 |
Secondary
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Vital Capacity (at Week 24) | -0.14 litres | Standard Error 0.03 |
| Tiotropium | Change From Baseline in Trough Forced Vital Capacity (at Week 24) | 0.07 litres | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.14, 0.28]ANCOVA
Secondary
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Vital Capacity (at Week 8) | -0.06 litres | Standard Deviation 0.33 |
| Tiotropium | Change From Baseline in Trough Forced Vital Capacity (at Week 8) | 0.16 litres | Standard Deviation 0.38 |
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time frame: baseline, week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) | -0.54 units on a scale | Standard Error 1.58 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) | -1.07 units on a scale | Standard Error 1.51 |
Comparison: tiotropium versus placebop-value: 0.76395% CI: [-4, 2.93]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) | 4.47 units on a scale | Standard Error 1.64 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) | 2.62 units on a scale | Standard Error 1.54 |
Comparison: tiotropium versus placebop-value: 0.31395% CI: [-5.45, 1.75]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time frame: baseline, week 20
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) | 4.32 units on a scale | Standard Error 1.62 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) | 3.52 units on a scale | Standard Error 1.7 |
Comparison: tiotropium versus placebop-value: 0.68295% CI: [-4.6, 3.01]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) | 5.26 units on a scale | Standard Error 1.64 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) | 1.51 units on a scale | Standard Error 1.54 |
Comparison: tiotropium versus placebop-value: 0.04395% CI: [-7.39, -0.13]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time frame: baseline, week 4
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) | 0.34 units on a scale | Standard Error 1.64 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) | 0.98 units on a scale | Standard Error 1.53 |
Comparison: tiotropium versus placebop-value: 0.72995% CI: [-2.97, 4.24]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) | 2.12 units on a scale | Standard Error 1.54 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) | -0.38 units on a scale | Standard Error 1.44 |
Comparison: tiotropium versus placebop-value: 0.14995% CI: [-5.9, 0.9]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time frame: baseline, week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) | -0.32 units on a scale | Standard Error 1.91 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) | 0.46 units on a scale | Standard Error 1.84 |
Comparison: tiotropium versus placebop-value: 0.75495% CI: [-4.12, 5.67]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) | 3.68 units on a scale | Standard Error 2.46 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) | 3.66 units on a scale | Standard Error 2.33 |
Comparison: tiotropium versus placebop-value: 0.99595% CI: [-6.31, 6.27]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time frame: baseline, week 20
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) | 4.27 units on a scale | Standard Error 2.55 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) | 3.08 units on a scale | Standard Error 2.44 |
Comparison: tiotropium versus placebop-value: 0.7295% CI: [-7.77, 5.39]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) | 4.04 units on a scale | Standard Error 2.43 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) | -1.84 units on a scale | Standard Error 2.29 |
Comparison: tiotropium versus placebop-value: 0.06495% CI: [-12.1, 0.35]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time frame: baseline, week 4
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) | -2.03 units on a scale | Standard Error 2.21 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) | -2.64 units on a scale | Standard Error 2.03 |
Comparison: tiotropium versus placebop-value: 0.82395% CI: [-6.01, 4.79]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) | 0.41 units on a scale | Standard Error 2.71 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) | -0.61 units on a scale | Standard Error 2.6 |
Comparison: tiotropium versus placebop-value: 0.76795% CI: [-7.86, 5.81]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time frame: baseline, week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) | 0.32 units on a scale | Standard Error 2.09 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) | 4.11 units on a scale | Standard Error 2.02 |
Comparison: tiotropium versus placebop-value: 0.16295% CI: [-1.55, 9.13]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) | 2.20 units on a scale | Standard Error 2.78 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) | 4.79 units on a scale | Standard Error 2.64 |
Comparison: tiotropium versus placebop-value: 0.47195% CI: [-4.51, 9.69]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time frame: baseline, week 20
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) | 3.93 units on a scale | Standard Error 2.58 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) | 4.10 units on a scale | Standard Error 2.5 |
Comparison: tiotropium versus placebop-value: 0.96195% CI: [-6.52, 6.84]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) | 2.20 units on a scale | Standard Error 2.7 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) | -2.70 units on a scale | Standard Error 2.5 |
Comparison: tiotropium versus placebop-value: 0.15895% CI: [-11.73, 1.94]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time frame: baseline, week 4
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) | -2.39 units on a scale | Standard Error 2.48 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) | -3.50 units on a scale | Standard Error 2.31 |
Comparison: tiotropium versus placebop-value: 0.71895% CI: [-7.21, 4.98]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) | -0.62 units on a scale | Standard Error 2.96 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) | -1.04 units on a scale | Standard Error 2.86 |
Comparison: tiotropium versus placebop-value: 0.91295% CI: [-7.9, 7.06]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time frame: baseline, week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) | 0.12 units on a scale | Standard Error 1.63 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) | 4.22 units on a scale | Standard Error 1.55 |
Comparison: tiotropium versus placebop-value: 0.05195% CI: [-0.02, 8.23]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) | -3.39 units on a scale | Standard Error 1.49 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) | 0.04 units on a scale | Standard Error 1.4 |
Comparison: tiotropium versus placebop-value: 0.07595% CI: [-0.35, 7.21]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time frame: baseline, week 20
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) | 0.51 units on a scale | Standard Error 1.13 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) | 2.00 units on a scale | Standard Error 1.08 |
Comparison: tiotropium versus placebop-value: 0.30695% CI: [-1.39, 4.38]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) | 0.96 units on a scale | Standard Error 2 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) | -1.37 units on a scale | Standard Error 1.86 |
Comparison: tiotropium versus placebop-value: 0.36395% CI: [-7.39, 2.73]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time frame: baseline, week 4
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) | -1.89 units on a scale | Standard Error 1.96 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) | -0.15 units on a scale | Standard Error 1.77 |
Comparison: tiotropium versus placebop-value: 0.46995% CI: [-3.01, 6.49]ANCOVA
Secondary
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) | -1.94 units on a scale | Standard Error 2.62 |
| Tiotropium | Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) | 3.85 units on a scale | Standard Error 2.43 |
Comparison: tiotropium versus placebop-value: 0.07995% CI: [-0.68, 12.26]ANCOVA
Secondary
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Forced expiratory volume in 1 second (baseline, 120 minutes)
Time frame: Baseline, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) | 1.75 litres | Standard Deviation 0.48 |
| Tiotropium | Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) | 1.92 litres | Standard Deviation 0.49 |
Secondary
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Forced expiratory volume in 1 second (baseline, 180 minutes)
Time frame: Baseline, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) | 1.76 litres | Standard Deviation 0.48 |
| Tiotropium | Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) | 1.94 litres | Standard Deviation 0.48 |
Secondary
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Forced expiratory volume in 1 second (baseline, 30 minutes)
Time frame: baseline, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) | 1.73 litres | Standard Deviation 0.45 |
| Tiotropium | Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) | 1.87 litres | Standard Deviation 0.47 |
Secondary
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Forced expiratory volume in 1 second (baseline, 60 minutes)
Time frame: baseline, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) | 1.74 litres | Standard Deviation 0.47 |
| Tiotropium | Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) | 1.90 litres | Standard Deviation 0.47 |
Secondary
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Forced expiratory volume in 1 second (baseline, pre-dose)
Time frame: Baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) | 1.71 litres | Standard Deviation 0.45 |
| Tiotropium | Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) | 1.74 litres | Standard Deviation 0.46 |
Secondary
Forced Vital Capacity (Baseline, 120 Minutes)
Forced vital capacity (baseline, 120 minutes)
Time frame: baseline, 120 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Vital Capacity (Baseline, 120 Minutes) | 3.21 litres | Standard Deviation 0.86 |
| Tiotropium | Forced Vital Capacity (Baseline, 120 Minutes) | 3.49 litres | Standard Deviation 0.85 |
Secondary
Forced Vital Capacity (Baseline, 180 Minutes)
Forced vital capacity (baseline, 180 minutes)
Time frame: baseline, 180 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Vital Capacity (Baseline, 180 Minutes) | 3.21 litres | Standard Deviation 0.83 |
| Tiotropium | Forced Vital Capacity (Baseline, 180 Minutes) | 3.50 litres | Standard Deviation 0.85 |
Secondary
Forced Vital Capacity (Baseline, 30 Minutes)
Forced vital capacity (baseline, 30 minutes)
Time frame: baseline, 30 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Vital Capacity (Baseline, 30 Minutes) | 3.20 litres | Standard Deviation 0.82 |
| Tiotropium | Forced Vital Capacity (Baseline, 30 Minutes) | 3.45 litres | Standard Deviation 0.83 |
Secondary
Forced Vital Capacity (Baseline, 60 Minutes)
Forced vital capacity (baseline, 60 minutes)
Time frame: baseline, 60 minutes
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Vital Capacity (Baseline, 60 Minutes) | 3.22 litres | Standard Deviation 0.85 |
| Tiotropium | Forced Vital Capacity (Baseline, 60 Minutes) | 3.48 litres | Standard Deviation 0.84 |
Secondary
Forced Vital Capacity (Baseline, Pre-dose)
Forced vital capacity (baseline, pre-dose)
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Vital Capacity (Baseline, Pre-dose) | 3.17 litres | Standard Deviation 0.82 |
| Tiotropium | Forced Vital Capacity (Baseline, Pre-dose) | 3.24 litres | Standard Deviation 0.81 |
Secondary
FVC AUC0-3 at Baseline
Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FVC AUC0-3 at Baseline | 3.17 litres * hours | Standard Deviation 0.82 |
| Tiotropium | FVC AUC0-3 at Baseline | 3.24 litres * hours | Standard Deviation 0.81 |
Secondary
FVC AUC0-3 at Week 16 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
Time frame: baseline, week 16
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FVC AUC0-3 at Week 16 Minus Baseline | -0.06 litres * hours | Standard Deviation 0.39 |
| Tiotropium | FVC AUC0-3 at Week 16 Minus Baseline | 0.24 litres * hours | Standard Deviation 0.43 |
Secondary
FVC AUC0-3 at Week 24 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Time frame: baseline, week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FVC AUC0-3 at Week 24 Minus Baseline | -0.11 litres * hours | Standard Error 0.03 |
| Tiotropium | FVC AUC0-3 at Week 24 Minus Baseline | 0.19 litres * hours | Standard Error 0.03 |
Comparison: tiotropium versus placebop-value: <0.00195% CI: [0.24, 0.38]ANCOVA
Secondary
FVC AUC0-3 at Week 8 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
Time frame: baseline, week 8
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FVC AUC0-3 at Week 8 Minus Baseline | -0.01 litres * hours | Standard Deviation 0.35 |
| Tiotropium | FVC AUC0-3 at Week 8 Minus Baseline | 0.28 litres * hours | Standard Deviation 0.39 |
Secondary
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Poor/Fair | 72 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Good | 111 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Excellent | 23 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Poor/Fair | 95 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Good | 117 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | Excellent | 15 Participants |
Comparison: tiotropium versus placebop-value: 0.223Cochran-Mantel-Haenszel
Secondary
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Poor/Fair | 62 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Good | 127 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Excellent | 17 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Poor/Fair | 53 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Good | 132 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | Excellent | 35 Participants |
Comparison: tiotropium versus placebop-value: 0.01Cochran-Mantel-Haenszel
Secondary
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Poor/Fair | 66 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Good | 116 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Excellent | 19 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Poor/Fair | 56 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Good | 128 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | Excellent | 32 Participants |
Comparison: tiotropium versus placebop-value: 0.086Cochran-Mantel-Haenszel
Secondary
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Poor/Fair | 62 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Good | 122 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Excellent | 23 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Poor/Fair | 78 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Good | 132 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | Excellent | 17 Participants |
Comparison: tiotropium versus placebop-value: 0.174Cochran-Mantel-Haenszel
Secondary
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: week 12
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Poor/Fair | 49 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Good | 135 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Excellent | 20 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Poor/Fair | 50 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Good | 134 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | Excellent | 36 Participants |
Comparison: tiotropium versus placebop-value: 0.186Cochran-Mantel-Haenszel
Secondary
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time frame: week 24
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Poor/Fair | 51 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Good | 128 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Excellent | 22 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Poor/Fair | 41 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Good | 136 Participants |
| Tiotropium | Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | Excellent | 39 Participants |
Comparison: tiotropium versus placebop-value: 0.045Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Baseline)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: baseline
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Baseline) | Yes | 126 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Baseline) | No | 58 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Baseline) | Yes | 143 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Baseline) | No | 60 Participants |
Comparison: tiotropium versus placebop-value: 0.996Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 12)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 12
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 12) | Yes | 118 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 12) | No | 71 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 12) | Yes | 139 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 12) | No | 60 Participants |
Comparison: tiotropium versus placebop-value: 0.215Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 16)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 16
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 16) | No | 71 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 16) | Yes | 116 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 16) | No | 60 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 16) | Yes | 133 Participants |
Comparison: tiotropium versus placebop-value: 0.205Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 20)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 20
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 20) | No | 61 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 20) | Yes | 127 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 20) | No | 56 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 20) | Yes | 134 Participants |
Comparison: tiotropium versus placebop-value: 0.622Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 24)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 24
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 24) | Yes | 118 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 24) | No | 64 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 24) | Yes | 136 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 24) | No | 60 Participants |
Comparison: tiotropium versus placebop-value: 0.446Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 4)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 4
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 4) | Yes | 129 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 4) | No | 58 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 4) | Yes | 154 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 4) | No | 50 Participants |
Comparison: tiotropium versus placebop-value: 0.196Cochran-Mantel-Haenszel
Secondary
Number of Participants With Healthy Lifestyle (Week 8)
Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time frame: week 8
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Healthy Lifestyle (Week 8) | Yes | 125 Participants |
| Placebo | Number of Participants With Healthy Lifestyle (Week 8) | No | 66 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 8) | Yes | 137 Participants |
| Tiotropium | Number of Participants With Healthy Lifestyle (Week 8) | No | 60 Participants |
Comparison: tiotropium versus placebop-value: 0.8Cochran-Mantel-Haenszel
Secondary
Number of Steps Per Day (Baseline)
Number of steps per day (baseline)
Time frame: baseline
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Steps Per Day (Baseline) | 7343.4 Steps | Standard Deviation 3711.8 |
| Tiotropium | Number of Steps Per Day (Baseline) | 7366.1 Steps | Standard Deviation 3816 |
Secondary
Peak Forced Expiratory Volume in 1 Second (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time frame: Baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak Forced Expiratory Volume in 1 Second (Baseline) | 1.71 litres | Standard Deviation 0.45 |
| Tiotropium | Peak Forced Expiratory Volume in 1 Second (Baseline) | 1.74 litres | Standard Deviation 0.46 |
Secondary
Peak Forced Vital Capacity (FVC) (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak Forced Vital Capacity (FVC) (Baseline) | 3.17 litres | Standard Deviation 0.82 |
| Tiotropium | Peak Forced Vital Capacity (FVC) (Baseline) | 3.24 litres | Standard Deviation 0.81 |
Secondary
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm.
Time frame: baseline
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | 6.9 ln(minutes) | Standard Deviation 0.24 |
| Tiotropium | Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | 6.8 ln(minutes) | Standard Deviation 0.27 |
Secondary
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time frame: baseline
Population: Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for \>= 12 weeks, and who wore the activity monitor for \>11 hours for at least 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | 4.2 ln(minutes) | Standard Deviation 0.96 |
| Tiotropium | Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | 4.3 ln(minutes) | Standard Deviation 0.92 |
Secondary
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: Baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) | 1.71 litres | Standard Deviation 0.45 |
| Tiotropium | Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) | 1.74 litres | Standard Deviation 0.46 |
Secondary
Trough Forced Vital Capacity (Baseline)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Forced Vital Capacity (Baseline) | 3.17 litres | Standard Deviation 0.82 |
| Tiotropium | Trough Forced Vital Capacity (Baseline) | 3.24 litres | Standard Deviation 0.81 |
Secondary
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) | 25.4 units on a scale | Standard Deviation 21.43 |
| Tiotropium | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) | 28 units on a scale | Standard Deviation 22.32 |
Secondary
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health | 17.2 units on a scale | Standard Deviation 20.24 |
| Tiotropium | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health | 21.1 units on a scale | Standard Deviation 21.08 |
Secondary
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) | 19.3 units on a scale | Standard Deviation 22.17 |
| Tiotropium | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) | 22.0 units on a scale | Standard Deviation 22.06 |
Secondary
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time frame: baseline
Population: Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) | 5.5 units on a scale | Standard Deviation 19.31 |
| Tiotropium | Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) | 2.7 units on a scale | Standard Deviation 12.35 |