Phase 4
Completed N=457
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00523991 ↗
Enrolled (actual)
457
Serious AEs
4.6%
Results posted
Dec 2011
Primary outcomePrimary: 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; 0.16 litres * hours — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
-0.06; 0.16 | <0.001 sig |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) |
1.71; 1.74 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) |
-0.03; 0.12 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) |
-0.06; 0.09 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) |
-0.08; 0.06 | <0.001 sig |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (Baseline) |
1.71; 1.74 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) |
0.09; 0.31 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) |
0.05; 0.29 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) |
0.02; 0.26 | <0.001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) |
1.71; 1.74 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) |
1.73; 1.87 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) |
1.74; 1.90 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) |
1.75; 1.92 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) |
1.76; 1.94 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) |
-0.03; 0.12 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) |
0.00; 0.20 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) |
0.01; 0.22 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) |
0.01; 0.24 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) |
0.01; 0.24 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) |
-0.06; 0.09 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) |
-0.02; 0.19 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) |
-0.02; 0.21 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) |
-0.03; 0.22 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) |
-0.02; 0.22 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) |
-0.08; 0.06 | <0.001 sig |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) |
-0.05; 0.15 | <0.001 sig |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) |
-0.05; 0.18 | <0.001 sig |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) |
-0.06; 0.18 | <0.001 sig |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) |
-0.05; 0.20 | <0.001 sig |
| SECONDARY FVC AUC0-3 at Baseline |
3.17; 3.24 | — |
| SECONDARY FVC AUC0-3 at Week 8 Minus Baseline |
-0.01; 0.28 | — |
| SECONDARY FVC AUC0-3 at Week 16 Minus Baseline |
-0.06; 0.24 | — |
| SECONDARY FVC AUC0-3 at Week 24 Minus Baseline |
-0.11; 0.19 | <0.001 sig |
| SECONDARY Trough Forced Vital Capacity (Baseline) |
3.17; 3.24 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (at Week 8) |
-0.06; 0.16 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (at Week 16) |
-0.13; 0.10 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (at Week 24) |
-0.14; 0.07 | <0.001 sig |
| SECONDARY Peak Forced Vital Capacity (FVC) (Baseline) |
3.17; 3.24 | — |
| SECONDARY Change From Baseline in Peak Forced Vital Capacity (at Week 8) |
0.13; 0.43 | — |
| SECONDARY Change From Baseline in Peak Forced Vital Capacity (at Week 16) |
0.08; 0.38 | — |
| SECONDARY Change From Baseline in Peak Forced Vital Capacity (at Week 24) |
0.06; 0.40 | <0.001 sig |
| SECONDARY Forced Vital Capacity (Baseline, Pre-dose) |
3.17; 3.24 | — |
| SECONDARY Forced Vital Capacity (Baseline, 30 Minutes) |
3.20; 3.45 | — |
| SECONDARY Forced Vital Capacity (Baseline, 60 Minutes) |
3.22; 3.48 | — |
| SECONDARY Forced Vital Capacity (Baseline, 120 Minutes) |
3.21; 3.49 | — |
| SECONDARY Forced Vital Capacity (Baseline, 180 Minutes) |
3.21; 3.50 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) |
-0.06; 0.16 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) |
0.00; 0.27 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) |
0.00; 0.29 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) |
-0.02; 0.30 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) |
0.00; 0.30 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) |
-0.13; 0.10 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) |
-0.06; 0.24 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) |
-0.05; 0.27 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) |
-0.05; 0.26 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) |
-0.05; 0.26 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) |
-0.14; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) |
-0.10; 0.19 | <0.001 sig |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) |
-0.07; 0.23 | <0.001 sig |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) |
-0.11; 0.22 | <0.001 sig |
| SECONDARY Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) |
-0.07; 0.29 | <0.001 sig |
| SECONDARY Albuterol Use p.r.n. (Baseline) |
2.1; 1.8 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. - (Week 4) |
-0.2; -0.2 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. - (Week 8) |
-0.3; -0.3 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. -(Week 12) |
-0.3; -0.3 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. - (Week 16) |
-0.4; -0.3 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. -(Week 20) |
-0.4; -0.3 | — |
| SECONDARY Change From Baseline in Albuterol Use p.r.n. - (Week 24) |
-0.64; -0.62 | 0.927 |
| SECONDARY Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) |
62; 78; 122; 132; 23; 17 | 0.174 |
| SECONDARY Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) |
49; 50; 135; 134; 20; 36 | 0.186 |
| SECONDARY Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) |
51; 41; 128; 136; 22; 39 | 0.045 sig |
| SECONDARY Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) |
72; 95; 111; 117; 23; 15 | 0.223 |
| SECONDARY Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) |
62; 53; 127; 132; 17; 35 | 0.010 sig |
| SECONDARY Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) |
66; 56; 116; 128; 19; 32 | 0.086 |
| SECONDARY Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) |
25.4; 28 | — |
| SECONDARY 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; 0.98 | 0.729 |
| SECONDARY 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; -0.38 | 0.149 |
| SECONDARY 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; -1.07 | 0.763 |
| SECONDARY 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; 2.62 | 0.313 |
| SECONDARY 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; 3.52 | 0.682 |
| SECONDARY 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; 1.51 | 0.043 sig |
| SECONDARY Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health |
17.2; 21.1 | — |
| 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) |
-2.03; -2.64 | 0.823 |
| 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) |
0.41; -0.61 | 0.767 |
| 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) |
-0.32; 0.46 | 0.754 |
| 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) |
3.68; 3.66 | 0.995 |
| 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) |
4.27; 3.08 | 0.720 |
| 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) |
4.04; -1.84 | 0.064 |
| SECONDARY Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) |
19.3; 22.0 | — |
| 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) |
-2.39; -3.50 | 0.718 |
| 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) |
-0.62; -1.04 | 0.912 |
| 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) |
0.32; 4.11 | 0.162 |
| 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) |
2.20; 4.79 | 0.471 |
| 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) |
3.93; 4.10 | 0.961 |
| 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) |
2.20; -2.70 | 0.158 |
| SECONDARY Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) |
5.5; 2.7 | — |
| 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) |
-1.89; -0.15 | 0.469 |
| 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) |
-1.94; 3.85 | 0.079 |
| 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) |
0.12; 4.22 | 0.051 |
| 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) |
-3.39; 0.04 | 0.075 |
| 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) |
0.51; 2.00 | 0.306 |
| 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) |
0.96; -1.37 | 0.363 |
| SECONDARY Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day |
6.9; 6.8 | — |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day |
0.03; 0.02 | 0.668 |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day |
0.02; 0.03 | 0.780 |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day |
0.03; 0.02 | 0.610 |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day |
0.03; 0.04 | 0.554 |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day |
0.03; 0.04 | 0.549 |
| SECONDARY Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day |
0.02; 0.03 | 0.568 |
| SECONDARY Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day |
4.2; 4.3 | — |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day |
-0.06; -0.12 | 0.358 |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day |
0.01; -0.06 | 0.219 |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day |
-0.14; -0.09 | 0.518 |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day |
-0.26; -0.20 | 0.455 |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day |
-0.20; -0.20 | 0.927 |
| SECONDARY Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day |
-0.19; -0.20 | 0.933 |
| SECONDARY Number of Participants With Healthy Lifestyle (Baseline) |
126; 143; 58; 60 | 0.996 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 4) |
129; 154; 58; 50 | 0.196 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 8) |
125; 137; 66; 60 | 0.800 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 12) |
118; 139; 71; 60 | 0.215 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 16) |
116; 133; 71; 60 | 0.205 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 20) |
127; 134; 61; 56 | 0.622 |
| SECONDARY Number of Participants With Healthy Lifestyle (Week 24) |
118; 136; 64; 60 | 0.446 |
| SECONDARY Active Energy Expenditure (Baseline) |
0.87; 0.87 | — |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 4) |
-0.04; -0.03 | 0.819 |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 8) |
0.01; -0.03 | 0.204 |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 12) |
-0.05; -0.06 | 0.670 |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 16) |
-0.07; -0.09 | 0.630 |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 20) |
-0.08; -0.09 | 0.704 |
| SECONDARY Change From Baseline in Active Energy Expenditure (Week 24) |
-0.08; -0.10 | 0.579 |
| SECONDARY Number of Steps Per Day (Baseline) |
7343.4; 7366.1 | — |
| SECONDARY Change From Baseline in Number of Steps Per Day (Week 4) |
-263.91; -287.45 | 0.916 |
| SECONDARY Change From Baseline in Number of Steps Per Day(Week 8) |
-121.66; -153.09 | 0.899 |
| SECONDARY Change From Baseline in Number of Steps Per Day (Week 12) |
-351.30; -169.31 | 0.495 |
| SECONDARY Change From Baseline in Number of Steps Per Day (Week 16) |
-655.04; -396.21 | 0.318 |
| SECONDARY Change From Baseline in Number of Steps Per Day (Week 20) |
-408.34; -197.17 | 0.450 |
| SECONDARY Change From Baseline in Number of Steps Per Day (Week 24) |
-234.80; -183.34 | 0.858 |
Eligibility Criteria
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 50% and =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.
Data sourced from ClinicalTrials.gov (NCT00523991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.