Exercise, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
Interventions
Oral inhalation once daily of 18mcg tiotropium via handihaler
DRUGPlacebo
Oral inhalation of once-daily 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 No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients must sign an informed consent 2. Diagnosis of COPD with specific spirometric criteria (determined at study visits) 3. Age \>= 40 years 4. Medical Research Council Dyspnoea score \>= 2 5. Current or ex-smoker with a \>= 10 pack-year smoking history 6. Ability to exercise on treadmill
Exclusion criteria
1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment 2. Clinical history of asthma 3. Use of supplemental oxygen therapy 4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery) 5. Recent history (\<= 12 months) of myocardial infarction 6. Unstable or life-threatening cardiac arrhythmia 7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years 8. Pregnant or nursing women 9. Known hypersensitivity to anticholinergic drugs or any component of the study medications 10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1 11. Estimated life expectancy \< 2 years 12. Symptomatic prostatic hyperplasia or bladder neck obstruction 13. Known narrow-angle glaucoma 14. Any condition that is contraindicated for exercise 15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing 16. Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) |
| Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) |
| Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal) |
| Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase | baseline, 16 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase | baseline, 32 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase | baseline, 48 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase | baseline, 64 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase | baseline, 80 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent) |
| Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase | baseline, 96 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | baseline, 96 weeks | COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase | baseline, 8 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
| Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase | baseline, 100 weeks | FEV1 is the maximal amount of air you can forcefully exhale in one second. |
| Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase | baseline, 100 weeks | FVC is the volume of air that can be forcibly blown out after full inspiration. |
| Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase | baseline, 100 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase | baseline, 100 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase | baseline, 100 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase | baseline, 100 weeks | Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status. |
| Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | From first drug administration until 30 days after last drug administration | Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events. |
| 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase | baseline, 100 weeks | Efficacy was assessed by measuring the exercise duration during a treadmill exercise test. |
Countries
Argentina, Brazil, Canada, Germany, Italy, Portugal, Russia, Spain, Taiwan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients randomized to receive treatment with matching placebo | 259 |
| Tiotropium Patients randomized to treatment with Tiotropium 18 micrograms | 260 |
| Total | 519 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Phase | Adverse Event | 48 | 28 | 0 | 0 |
| Double-Blind Phase | Lack of Efficacy | 13 | 5 | 0 | 0 |
| Double-Blind Phase | Lost to Follow-up | 3 | 7 | 0 | 0 |
| Double-Blind Phase | Other reason (not specified) | 12 | 13 | 0 | 0 |
| Double-Blind Phase | Protocol Violation | 3 | 1 | 0 | 0 |
| Double-Blind Phase | Withdrawal by Subject | 17 | 12 | 0 | 0 |
| Open-Label Phase | Adverse Event | 0 | 0 | 1 | 0 |
| Open-Label Phase | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Open-Label Phase | Other reason (not specified) | 0 | 0 | 4 | 5 |
Baseline characteristics
| Characteristic | Total | Tiotropium | Placebo |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 8.3 | 64.7 years STANDARD_DEVIATION 8.2 | 64.5 years STANDARD_DEVIATION 8.5 |
| Age, Customized <= 55 | 75 participants | 38 participants | 37 participants |
| Age, Customized > 55 to <= 65 | 194 participants | 93 participants | 101 participants |
| Age, Customized > 65 | 250 participants | 129 participants | 121 participants |
| Alcohol status Drinks - no interference with study | 282 participants | 137 participants | 145 participants |
| Alcohol status Drinks - possible interference with study | 0 participants | 0 participants | 0 participants |
| Alcohol status Non drinker | 237 participants | 123 participants | 114 participants |
| Anticholinergic use at screening No | 278 participants | 139 participants | 139 participants |
| Anticholinergic use at screening Yes | 241 participants | 121 participants | 120 participants |
| BMI (Body Mass Index) | 26.4 kilograms / square meter STANDARD_DEVIATION 4.31 | 26.0 kilograms / square meter STANDARD_DEVIATION 4.38 | 26.8 kilograms / square meter STANDARD_DEVIATION 4.23 |
| Duration of COPD (Chronic Obstructive Pulmonary Disease) | 8.75 years STANDARD_DEVIATION 6.63 | 8.70 years STANDARD_DEVIATION 6.27 | 8.80 years STANDARD_DEVIATION 6.99 |
| Height | 169.7 centimeters STANDARD_DEVIATION 8.9 | 169.7 centimeters STANDARD_DEVIATION 9.2 | 169.6 centimeters STANDARD_DEVIATION 8.5 |
| ICS (Inhaled Cortico Steroid) use at randomization No | 209 participants | 101 participants | 108 participants |
| ICS (Inhaled Cortico Steroid) use at randomization Yes | 310 participants | 159 participants | 151 participants |
| LABA / ICS use at randomization No | 264 participants | 131 participants | 133 participants |
| LABA / ICS use at randomization Yes | 255 participants | 129 participants | 126 participants |
| LABA (Long Acting Beta Agonist) use at randomization No | 211 participants | 107 participants | 104 participants |
| LABA (Long Acting Beta Agonist) use at randomization Yes | 308 participants | 153 participants | 155 participants |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 4 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 36 participants | 22 participants | 14 participants |
| Race/Ethnicity, Customized Black / African American | 16 participants | 10 participants | 6 participants |
| Race/Ethnicity, Customized Hawaiian / Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 463 participants | 226 participants | 237 participants |
| Sex: Female, Male Female | 118 Participants | 61 Participants | 57 Participants |
| Sex: Female, Male Male | 401 Participants | 199 Participants | 202 Participants |
| Smoking history | 51.6 pack years STANDARD_DEVIATION 27.64 | 52.15 pack years STANDARD_DEVIATION 28.95 | 51.04 pack years STANDARD_DEVIATION 26.29 |
| Smoking Status Currently smokes | 176 participants | 91 participants | 85 participants |
| Smoking Status Ex-smoker | 343 participants | 169 participants | 174 participants |
| Smoking Status Never smoked | 0 participants | 0 participants | 0 participants |
| Weight | 76.4 kilograms STANDARD_DEVIATION 15.5 | 75.4 kilograms STANDARD_DEVIATION 16 | 77.4 kilograms STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 135 / 259 | 128 / 260 | 5 / 164 | 5 / 194 |
| serious Total, serious adverse events | 59 / 259 | 63 / 260 | 3 / 164 | 6 / 194 |
Outcome results
Primary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 96 weeks
Population: Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase | 297.1 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase | 336.6 seconds |
p-value: 0.106295% CI: [0.97, 1.32]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase | 337.25 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase | 358.80 seconds |
p-value: 0.444395% CI: [0.91, 1.25]ANCOVA
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase | 308.6 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase | 338.6 seconds |
p-value: 0.059795% CI: [1, 1.21]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 32 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase | 311.8 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase | 358.7 seconds |
p-value: 0.013195% CI: [1.03, 1.29]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 48 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase | 309.8 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase | 365.7 seconds |
p-value: 0.004195% CI: [1.05, 1.32]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 64 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase | 313.4 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase | 349.0 seconds |
p-value: 0.094595% CI: [0.98, 1.26]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 80 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase | 302.8 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase | 340.1 seconds |
p-value: 0.089995% CI: [0.98, 1.28]Mixed Models Analysis
Secondary
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase | 304.9 seconds |
| Tiotropium | 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase | 343.0 seconds |
p-value: 0.00895% CI: [1.03, 1.23]Mixed Models Analysis
Secondary
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase | 4.1 units on scale | Standard Error 0.16 |
| Tiotropium | Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase | 3.8 units on scale | Standard Error 0.14 |
p-value: 0.113195% CI: [-0.72, 0.08]Mixed Models Analysis
Secondary
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase | 5.6 unit on scale | Standard Error 0.14 |
| Tiotropium | Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase | 5.6 unit on scale | Standard Error 0.13 |
p-value: 0.907195% CI: [-0.38, 0.33]Mixed Models Analysis
Secondary
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase | 4.0 unit on scale | Standard Error 0.18 |
| Tiotropium | Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase | 4.1 unit on scale | Standard Error 0.16 |
p-value: 0.687895% CI: [-0.35, 0.53]Mixed Models Analysis
Secondary
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase | 0.07 units on scale | Standard Error 1.206 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase | 0.30 units on scale | Standard Error 1.159 |
95% CI: [-3.05, 3.51]
Secondary
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase | 0.13 units on scale | Standard Error 1.281 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase | 0.20 units on scale | Standard Error 1.225 |
95% CI: [-3.4, 3.55]
Secondary
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase | 0.02 units on scale | Standard Error 1.365 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase | 0.18 units on scale | Standard Error 1.349 |
95% CI: [-3.61, 3.92]
Secondary
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 64 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase | -0.02 units on scale | Standard Error 1.25 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase | 0.16 units on scale | Standard Error 1.424 |
95% CI: [-3.53, 3.9]
Secondary
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 80 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase | -0.08 units on scale | Standard Error 1.284 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase | 0.09 units on scale | Standard Error 1.269 |
95% CI: [-3.36, 3.71]
Secondary
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase | -0.03 units on scale | Standard Error 1.134 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase | 0.34 units on scale | Standard Error 1.138 |
95% CI: [-2.78, 3.52]
Secondary
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 96 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase | -0.04 units on scale | Standard Error 1.455 |
| Tiotropium | Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase | 0.03 units on scale | Standard Error 1.348 |
95% CI: [-3.82, 3.96]
Secondary
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase | 0.02 units on scale | Standard Error 1.068 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase | 0.35 units on scale | Standard Error 1.083 |
95% CI: [-2.66, 3.31]
Secondary
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase | -0.04 units on scale | Standard Error 1.153 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase | 0.30 units on scale | Standard Error 1.186 |
95% CI: [-2.91, 3.58]
Secondary
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase | 0.03 units on scale | Standard Error 1.143 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase | 0.25 units on scale | Standard Error 1.165 |
95% CI: [-2.97, 3.43]
Secondary
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 64 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase | 0.03 units on scale | Standard Error 1.168 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase | 0.25 units on scale | Standard Error 1.17 |
95% CI: [-3.02, 3.46]
Secondary
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 80 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase | -0.06 units on scale | Standard Error 1.217 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase | 0.10 units on scale | Standard Error 1.132 |
95% CI: [-3.1, 3.41]
Secondary
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase | -0.04 unit on scale | Standard Error 0.999 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase | 0.32 unit on scale | Standard Error 0.986 |
95% CI: [-2.39, 3.11]
Secondary
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Time frame: baseline, 96 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase | -0.07 units on scale | Standard Error 1.222 |
| Tiotropium | Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase | 0.10 units on scale | Standard Error 1.22 |
95% CI: [-3.22, 3.55]
Secondary
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status
Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
Time frame: From first drug administration until 30 days after last drug administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Blood pressure increased | 0 participants |
| Placebo | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Fatal | 6 participants |
| Placebo | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Oxygen saturation decreased | 1 participants |
| Placebo | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Weight decreased | 1 participants |
| Placebo | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Heart rate increased | 1 participants |
| Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Blood pressure increased | 2 participants |
| Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Weight decreased | 2 participants |
| Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Fatal | 6 participants |
| Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Heart rate increased | 1 participants |
| Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Oxygen saturation decreased | 0 participants |
| Placebo / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Heart rate increased | 1 participants |
| Placebo / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Fatal | 0 participants |
| Placebo / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Blood pressure increased | 0 participants |
| Placebo / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Oxygen saturation decreased | 0 participants |
| Placebo / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Weight decreased | 0 participants |
| Tiotropium / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Blood pressure increased | 0 participants |
| Tiotropium / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Heart rate increased | 0 participants |
| Tiotropium / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Fatal | 0 participants |
| Tiotropium / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Oxygen saturation decreased | 0 participants |
| Tiotropium / Open Tiotropium | Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status | Weight decreased | 0 participants |
Secondary
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase
COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.
Time frame: baseline, 96 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | Patients with exacerbations | 102 participants |
| Placebo | Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | Censored patients | 157 participants |
| Tiotropium | Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | Patients with exacerbations | 112 participants |
| Tiotropium | Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase | Censored patients | 148 participants |
p-value: 0.654195% CI: [0.719, 1.23]Regression, Cox
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase | 1.23 liters | Standard Error 0.02 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase | 1.23 liters | Standard Error 0.02 |
p-value: 0.864495% CI: [-0.05, 0.06]ANCOVA
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | 1.092 liters | Standard Error 0.017 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | 1.254 liters | Standard Error 0.017 |
p-value: <0.000195% CI: [0.117, 0.208]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 32 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | 1.113 liters | Standard Error 0.018 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | 1.259 liters | Standard Error 0.018 |
p-value: <0.000195% CI: [0.099, 0.192]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 48 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | 1.105 liters | Standard Error 0.019 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | 1.232 liters | Standard Error 0.018 |
p-value: <0.000195% CI: [0.077, 0.176]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 64 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | 1.097 liters | Standard Error 0.02 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | 1.230 liters | Standard Error 0.019 |
p-value: <0.000195% CI: [0.083, 0.185]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 80 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | 1.079 liters | Standard Error 0.02 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | 1.228 liters | Standard Error 0.019 |
p-value: <0.000195% CI: [0.097, 0.202]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | 1.126 liters | Standard Error 0.017 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | 1.280 liters | Standard Error 0.017 |
p-value: <0.000195% CI: [0.11, 0.198]Mixed Models Analysis
Secondary
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | 1.072 liters | Standard Error 0.021 |
| Tiotropium | Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | 1.202 liters | Standard Error 0.019 |
p-value: <0.000195% CI: [0.077, 0.183]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase | 2.72 liters | Standard Error 0.05 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase | 2.77 liters | Standard Error 0.05 |
p-value: 0.427795% CI: [-0.07, 0.17]ANCOVA
Secondary
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | 2.442 liters | Standard Error 0.039 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | 2.767 liters | Standard Error 0.037 |
p-value: <0.000195% CI: [0.226, 0.425]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 32 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | 2.462 liters | Standard Error 0.042 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | 2.816 liters | Standard Error 0.04 |
p-value: <0.000195% CI: [0.245, 0.461]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 48 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | 2.499 liters | Standard Error 0.041 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | 2.758 liters | Standard Error 0.039 |
p-value: <0.000195% CI: [0.154, 0.365]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 64 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | 2.466 liters | Standard Error 0.041 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | 2.767 liters | Standard Error 0.039 |
p-value: <0.000195% CI: [0.194, 0.406]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 80 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | 2.479 liters | Standard Error 0.043 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | 2.733 liters | Standard Error 0.04 |
p-value: <0.000195% CI: [0.144, 0.364]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | 2.529 liters | Standard Error 0.038 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | 2.806 liters | Standard Error 0.037 |
p-value: <0.000195% CI: [0.179, 0.375]Mixed Models Analysis
Secondary
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | 2.420 liters | Standard Error 0.048 |
| Tiotropium | Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | 2.753 liters | Standard Error 0.045 |
p-value: <0.000195% CI: [0.209, 0.456]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | 1.082 liters | Standard Error 0.018 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase | 1.164 liters | Standard Error 0.017 |
p-value: 0.000595% CI: [0.036, 0.128]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 32 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | 1.090 liters | Standard Error 0.019 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase | 1.179 liters | Standard Error 0.018 |
p-value: 0.000395% CI: [0.041, 0.137]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 48 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | 1.066 liters | Standard Error 0.019 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase | 1.172 liters | Standard Error 0.018 |
p-value: <0.000195% CI: [0.058, 0.153]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 64 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | 1.066 liters | Standard Error 0.02 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase | 1.157 liters | Standard Error 0.019 |
p-value: 0.000595% CI: [0.04, 0.141]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 80 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | 1.039 liters | Standard Error 0.019 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase | 1.134 liters | Standard Error 0.018 |
p-value: 0.000295% CI: [0.045, 0.144]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | 1.082 liters | Standard Error 0.017 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase | 1.198 liters | Standard Error 0.016 |
p-value: <0.000195% CI: [0.073, 0.16]Mixed Models Analysis
Secondary
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | 1.050 liters | Standard Error 0.021 |
| Tiotropium | Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase | 1.125 liters | Standard Error 0.019 |
p-value: 0.005995% CI: [0.022, 0.128]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | 2.407 liters | Standard Error 0.038 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase | 2.564 liters | Standard Error 0.037 |
p-value: 0.001995% CI: [0.058, 0.255]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 32 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | 2.425 liters | Standard Error 0.04 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase | 2.607 liters | Standard Error 0.038 |
p-value: 0.000695% CI: [0.078, 0.286]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 48 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | 2.406 liters | Standard Error 0.041 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase | 2.640 liters | Standard Error 0.038 |
p-value: <0.000195% CI: [0.13, 0.339]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 64 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | 2.423 liters | Standard Error 0.046 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase | 2.584 liters | Standard Error 0.044 |
p-value: 0.00995% CI: [0.04, 0.281]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 80 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | 2.343 liters | Standard Error 0.042 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase | 2.555 liters | Standard Error 0.04 |
p-value: 0.000295% CI: [0.102, 0.322]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | 2.432 liters | Standard Error 0.035 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase | 2.649 liters | Standard Error 0.034 |
p-value: <0.000195% CI: [0.127, 0.307]Mixed Models Analysis
Secondary
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | 2.368 liters | Standard Error 0.044 |
| Tiotropium | Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase | 2.609 liters | Standard Error 0.041 |
p-value: <0.000195% CI: [0.128, 0.355]Mixed Models Analysis
Secondary
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase | 53.57 units on scale | Standard Error 1.57 |
| Tiotropium | Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase | 54.46 units on scale | Standard Error 1.49 |
p-value: 0.655695% CI: [-3.03, 4.81]ANCOVA
Secondary
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase | 56.9 units on scale | Standard Error 1.39 |
| Tiotropium | Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase | 54.6 units on scale | Standard Error 1.32 |
p-value: 0.202995% CI: [-5.91, 1.26]Mixed Models Analysis
Secondary
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase | 29.65 units on scale | Standard Error 1.38 |
| Tiotropium | Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase | 29.67 units on scale | Standard Error 1.31 |
p-value: 0.989695% CI: [-3.44, 3.48]ANCOVA
Secondary
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase | 34.0 units on scale | Standard Error 1.25 |
| Tiotropium | Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase | 30.4 units on scale | Standard Error 1.2 |
p-value: 0.031395% CI: [-6.84, -0.32]Mixed Models Analysis
Secondary
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase | 45.47 units on scale | Standard Error 1.94 |
| Tiotropium | Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase | 41.14 units on scale | Standard Error 1.85 |
p-value: 0.080795% CI: [-9.19, 0.53]ANCOVA
Secondary
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase | 54.4 units on scale | Standard Error 1.73 |
| Tiotropium | Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase | 45.5 units on scale | Standard Error 1.63 |
p-value: 0.000195% CI: [-13.37, -4.52]Mixed Models Analysis
Secondary
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 100 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase | 39.82 units on scale | Standard Error 1.28 |
| Tiotropium | Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase | 39.21 units on scale | Standard Error 1.21 |
p-value: 0.707195% CI: [-3.81, 2.59]ANCOVA
Secondary
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Time frame: baseline, 96 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase | 44.5 units on scale | Standard Error 1.13 |
| Tiotropium | Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase | 40.5 units on scale | Standard Error 1.07 |
p-value: 0.007295% CI: [-6.97, -1.1]Mixed Models Analysis