Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
Interventions
DRUGtiotropium
DRUGCombivent (Ipratropium/Albuterol)
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years * Current or ex-smoker with a \>= 10 pack-year smoking history * Use of Combivent® Metered Dose Inhaler (MDI)for \>= 1 month prior to Visit 1 Spirometric criteria (determined at study visits): * Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \<= 70% (Visit 1) * Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/Forced Vital Capacity (FVC) \<= 70% (Visit 2)
Exclusion criteria
Clinical history of asthma * History of thoracotomy with pulmonary resection * History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease * Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests * Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1 * Recent history 6 months or less of Myocardial Infarction * Unstable or life-threatening cardiac arrhythmias * Hospitalization for Congestive Heart Failure during past year * Malignancy for which patient is receiving chemo or radiation therapy * Pregnant or nursing women * Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose * Use of SPIRIVA® 3 months prior to Visit 1 * Symptomatic of prostatic hypertrophy or bladder neck obstruction * Known narrow- angle glaucoma * Participating in a pulmonary rehab program within 4 weeks of Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks | Baseline and 12 Weeks | Trough FEV1 is measured 10 minutes before drug administration |
| Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | Baseline and 12 Weeks | Average hourly FEV1 AUC0-6 minus baseline FEV1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 at 3 Hours at Week 12 | 3 hour | — |
| FEV1 at 4 Hours at Week 12 | 4 hour | — |
| FEV1 at 6 Hours at Week 12 | 6 hour | — |
| FVC at 15 Minutes on Day 1 | 15 minutes | — |
| FVC at 30 Minutes on Day 1 | 30 minutes | — |
| FVC at 1 Hour on Day 1 | 1 hour | — |
| FVC at 2 Hours on Day 1 | 2 hour | — |
| FVC at 3 Hours on Day 1 | 3 hour | — |
| FVC at 4 Hours on Day 1 | 4 hour | — |
| FVC at 6 Hours on Day 1 | 6 hour | — |
| FVC at -10 Minutes at Week 6 | 10 minutes before dosing | — |
| FVC at 15 Minutes at Week 6 | 15 minutes | — |
| FVC at 30 Minutes at Week 6 | 30 minutes | — |
| FVC at 1 Hour at Week 6 | 1 hour | — |
| FVC at 2 Hours at Week 6 | 2 hour | — |
| FVC at 3 Hours at Week 6 | 3 hour | — |
| FVC at 4 Hours at Week 6 | 4 hour | — |
| FVC at 6 Hours at Week 6 | 6 hour | — |
| FVC at -10 Minutes at Week 12 | 10 minutes before dosing | — |
| FVC at 15 Minutes at Week 12 | 15 minutes | — |
| FVC at 30 Minutes at Week 12 | 30 minutes | — |
| FVC at 1 Hour at Week 12 | 1 hour | — |
| FVC at 2 Hours at Week 12 | 2 hour | — |
| FVC at 3 Hours at Week 12 | 3 hour | — |
| FVC at 4 Hours at Week 12 | 4 hour | — |
| FVC at 6 Hours at Week 12 | 6 hour | — |
| Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks | Baseline and 12 weeks | Trough FVC is measured 10 minutes before drug administration |
| Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 | Baseline and 12 weeks | Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication |
| FEV1 at 4 Hours at Week 6 | 4 hour | — |
| Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks | Baseline and 6 Weeks | Trough FEV1 is measured 10 minutes before drug administration |
| Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | Day 1 (after first dose) | Average hourly FEV1 AUC0-6 minus baseline FEV1 |
| Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 | Baseline and week 6 | Average hourly FEV1 AUC0-6 minus baseline FEV1 |
| Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 | Day 1 | Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication |
| Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 | Baseline and 6 weeks | Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication |
| Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | Baseline and 12 Weeks | Average hourly FVC AUC0-6 minus baseline FVC |
| Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks | Baseline and 6 weeks | Trough FVC is measured 10 minutes before drug administration |
| Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | Day 1 | Average hourly FVC AUC0-6 minus baseline FVC |
| FEV1 at 6 Hours at Week 6 | 6 hour | — |
| FEV1 at -10 Minutes at Week 12 | 10 minutes before dosing | — |
| FEV1 at 15 Minutes at Week 12 | 15 minutes | — |
| Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks | Baseline and 6 Weeks | Average hourly FVC AUC0-6 minus baseline FVC |
| Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 | Day 1 | Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication |
| Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 | baseline and 6 Weeks (after first dose) | Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication |
| FEV1 at 30 Minutes at Week 12 | 30 minutes | — |
| Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 | Baseline and 12 Weeks | Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication |
| FEV1 at 15 Minutes on Day 1 | 15 minutes | — |
| FEV1 at 30 Minutes on Day 1 | 30 minutes | — |
| FEV1 at 1 Hour on Day 1 | 1 hour | — |
| FEV1 at 2 Hours on Day 1 | 2 hour | — |
| FEV1 at 3 Hours on Day 1 | 3 hour | — |
| FEV1 at 4 Hours on Day 1 | 4 hour | — |
| FEV1 at 6 Hours on Day 1 | 6 hours | — |
| FEV1 at -10 Minutes at Week 6 | 10 minutes before dosing | — |
| FEV1 at 15 Minutes at Week 6 | 15 minutes | — |
| FEV1 at 30 Minutes at Week 6 | 30 minutes | — |
| FEV1 at 1 Hour at Week 6 | 1 hour | — |
| FEV1 at 2 Hours at Week 6 | 2 hour | — |
| FEV1 at 3 Hours at Week 6 | 3 hour | — |
| Day Time Albuterol Use During Week 1 | Week 1 | Puffs of rescue albuterol used during the day in week 1 |
| Day Time Albuterol Use During Week 2 | Week 2 | Puffs of rescue albuterol used during the day in week 2 |
| Day Time Albuterol Use During Week 3 | Week 3 | Puffs of rescue albuterol used during the day in week 3 |
| Day Time Albuterol Use During Week 4 | Week 4 | Puffs of rescue albuterol used during the day in week 4 |
| Day Time Albuterol Use During Week 5 | Week 5 | Puffs of rescue albuterol used during the day in week 5 |
| Day Time Albuterol Use During Week 6 | Week 6 | Puffs of rescue albuterol used during the day in week 6 |
| Day Time Albuterol Use During Week 7 | Week 7 | Puffs of rescue albuterol used during the day in week 7 |
| Day Time Albuterol Use During Week 8 | Week 8 | Puffs of rescue albuterol used during the day in week 8 |
| Day Time Albuterol Use During Week 9 | Week 9 | Puffs of rescue albuterol used during the day in week 9 |
| Day Time Albuterol Use During Week 10 | Week 10 | Puffs of rescue albuterol used during the day in week 10 |
| Day Time Albuterol Use During Week 11 | Week 11 | Puffs of rescue albuterol used during the day in week 11 |
| Day Time Albuterol Use During Week 12 | Week 12 | Puffs of rescue albuterol used during the day in week 12 |
| Night Time Albuterol Use During Week 1 | Week 1 | — |
| Night Time Albuterol Use During Week 2 | Week 2 | Puffs of rescue albuterol used during the night in week 2 |
| Night Time Albuterol Use During Week 3 | Week 3 | Puffs of rescue albuterol used during the night in week 3 |
| Night Time Albuterol Use During Week 4 | Week 4 | Puffs of rescue albuterol used during the night in week 4 |
| Night Time Albuterol Use During Week 5 | Week 5 | Puffs of rescue albuterol used during the night in week 5 |
| Night Time Albuterol Use During Week 6 | Week 6 | Puffs of rescue albuterol used during the night in week 6 |
| Night Time Albuterol Use During Week 7 | Week 7 | Puffs of rescue albuterol used during the night in week 7 |
| Night Time Albuterol Use During Week 8 | Week 8 | Puffs of rescue albuterol used during the night in week 8 |
| Night Time Albuterol Use During Week 9 | Week 9 | Puffs of rescue albuterol used during the night in week 9 |
| Night Time Albuterol Use During Week 10 | Week 10 | Puffs of rescue albuterol used during the night in week 10 |
| Night Time Albuterol Use During Week 11 | Week 11 | Puffs of rescue albuterol used during the night in week 11 |
| Night Time Albuterol Use During Week 12 | Week 12 | Puffs of rescue albuterol used during the night in week 12 |
| Morning Peak Expiratory Flow Rate (PEFR) at Week 1 | Week 1 | — |
| Morning PEFR at Week 2 | Week 2 | Weekly means for morning PEFR |
| Morning PEFR at Week 3 | Week 3 | Weekly means for morning PEFR |
| Morning PEFR at Week 4 | Week 4 | Weekly means for morning PEFR |
| Morning PEFR at Week 5 | Week 5 | Weekly means for morning PEFR |
| Morning PEFR at Week 6 | Week 6 | Weekly means for morning PEFR |
| Morning PEFR at Week 7 | Week 7 | Weekly means for morning PEFR |
| Morning PEFR at Week 8 | Week 8 | Weekly means for morning PEFR |
| Morning PEFR at Week 9 | Week 9 | Weekly means for morning PEFR |
| Morning PEFR at Week 10 | Week 10 | Weekly means for morning PEFR |
| Morning PEFR at Week 11 | Week 11 | Weekly means for morning PEFR |
| Morning PEFR at Week 12 | Week 12 | Weekly means for morning PEFR |
| Evening PEFR at Week 1 | Week 1 | Weekly means for evening PEFR |
| FEV1 at 1 Hour at Week 12 | 1 hour | — |
| Evening PEFR at Week 3 | Week 3 | Weekly means for evening PEFR |
| Evening PEFR at Week 4 | Week 4 | Weekly means for evening PEFR |
| Evening PEFR at Week 5 | Week 5 | Weekly means for evening PEFR |
| Evening PEFR at Week 6 | Week 6 | Weekly means for evening PEFR |
| Evening PEFR at Week 7 | Week 7 | Weekly means for evening PEFR |
| Evening PEFR at Week 8 | Week 8 | Weekly means for evening PEFR |
| Evening PEFR at Week 9 | Week 9 | Weekly means for evening PEFR |
| Evening PEFR at Week 10 | Week 10 | Weekly means for evening PEFR |
| Evening PEFR at Week 11 | Week 11 | Weekly means for evening PEFR |
| Evening PEFR at Week 12 | Week 12 | Weekly means for evening PEFR |
| Patient Global Evaluation | Week 6 | The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8) |
| Physician Global Evaluation | Week 6 | The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8). |
| Evening PEFR at Week 2 | Week 2 | Weekly means for evening PEFR |
| FEV1 at 2 Hours at Week 12 | 2 hour | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium 18 mcg once daily | 173 |
| Combivent (Ipratropium/Albuterol) 2 actuations 4 times daily | 176 |
| Total | 349 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 10 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Tiotropium | Combivent (Ipratropium/Albuterol) | Total |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 7.7 | 65.4 years STANDARD_DEVIATION 8 | 65.1 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 20 Participants | 13 Participants | 33.0 Participants |
| Sex: Female, Male Male | 153 Participants | 163 Participants | 316.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 173 | 9 / 176 |
| serious Total, serious adverse events | 11 / 173 | 12 / 176 |
Outcome results
Primary
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time frame: Baseline and 12 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | 0.187 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | 0.167 Liters | Standard Error 0.018 |
p-value: 0.004295% CI: [-0.032, 0.072]ANCOVA
Primary
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Time frame: Baseline and 12 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks | 0.081 Liters | Standard Error 0.018 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks | -0.025 Liters | Standard Error 0.018 |
p-value: <0.000195% CI: [0.055, 0.157]ANCOVA
Secondary
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time frame: Baseline and week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 | 0.207 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 | 0.153 Liters | Standard Error 0.018 |
p-value: 0.044795% CI: [0.001, 0.106]ANCOVA
Secondary
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FEV1 AUC0-6 minus baseline FEV1
Time frame: Day 1 (after first dose)
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | 0.132 Liters | Standard Error 0.012 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | 0.211 Liters | Standard Error 0.012 |
p-value: <0.000195% CI: [-0.114, -0.046]ANCOVA
Secondary
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Time frame: Baseline and 12 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | 0.443 Liters | Standard Error 0.037 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks | 0.432 Liters | Standard Error 0.036 |
p-value: 0.83595% CI: [-0.092, 0.114]ANCOVA
Secondary
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Time frame: Baseline and 6 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks | 0.464 Liters | Standard Error 0.035 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks | 0.425 Liters | Standard Error 0.035 |
p-value: 0.438695% CI: [-0.059, 0.137]ANCOVA
Secondary
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FVC AUC0-6 minus baseline FVC
Time frame: Day 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | 0.327 Liters | Standard Error 0.028 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 | 0.484 Liters | Standard Error 0.028 |
p-value: <0.000195% CI: [-0.236, -0.078]ANCOVA
Secondary
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time frame: Baseline and 12 weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 | 0.209 Liters | Standard Error 0.015 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 | 0.342 Liters | Standard Error 0.015 |
p-value: <0.000195% CI: [-0.175, -0.091]ANCOVA
Secondary
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time frame: Baseline and 6 weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 | 0.204 Liters | Standard Error 0.014 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 | 0.356 Liters | Standard Error 0.013 |
p-value: <0.000195% CI: [-0.19, -0.113]ANCOVA
Secondary
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Time frame: Day 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 | 0.232 Liters | Standard Error 0.014 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 | 0.364 Liters | Standard Error 0.014 |
p-value: <0.000195% CI: [-0.171, -0.092]ANCOVA
Secondary
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time frame: Baseline and 12 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 | 0.418 Liters | Standard Error 0.032 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 | 0.703 Liters | Standard Error 0.032 |
p-value: <0.000195% CI: [-0.375, -0.196]ANCOVA
Secondary
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time frame: baseline and 6 Weeks (after first dose)
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 | 0.43 Liters | Standard Error 0.031 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 | 0.791 Liters | Standard Error 0.031 |
p-value: <0.000195% CI: [-0.449, -0.274]ANCOVA
Secondary
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Time frame: Day 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 | 0.542 Liters | Standard Error 0.033 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 | 0.824 Liters | Standard Error 0.032 |
p-value: 0.000195% CI: [-0.374, -0.191]ANCOVA
Secondary
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Time frame: Baseline and 6 Weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks | 0.11 Liters | Standard Error 0.017 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks | -0.036 Liters | Standard Error 0.017 |
p-value: <0.000195% CI: [0.098, 0.193]ANCOVA
Secondary
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Trough FVC is measured 10 minutes before drug administration
Time frame: Baseline and 12 weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks | 0.225 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks | 0.051 Liters | Standard Error 0.038 |
p-value: 0.001595% CI: [0.067, 0.283]ANCOVA
Secondary
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Trough FVC is measured 10 minutes before drug administration
Time frame: Baseline and 6 weeks
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks | 0.258 Liters | Standard Error 0.036 |
| Combivent (Ipratropium/Albuterol) | Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks | -0.02 Liters | Standard Error 0.035 |
p-value: <0.000195% CI: [0.178, 0.379]ANCOVA
Secondary
Day Time Albuterol Use During Week 1
Puffs of rescue albuterol used during the day in week 1
Time frame: Week 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 1 | 1.175 Puffs per day | Standard Error 0.084 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 1 | 1.217 Puffs per day | Standard Error 0.082 |
p-value: 0.719695% CI: [-0.275, 0.19]ANCOVA
Secondary
Day Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the day in week 10
Time frame: Week 10
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 10 | 1.351 Puffs per day | Standard Error 0.116 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 10 | 1.394 Puffs per day | Standard Error 0.114 |
p-value: 0.794795% CI: [-0.367, 0.282]ANCOVA
Secondary
Day Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the day in week 11
Time frame: Week 11
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 11 | 1.352 Puffs per day | Standard Error 0.127 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 11 | 1.445 Puffs per day | Standard Error 0.124 |
p-value: 0.604995% CI: [-0.446, 0.26]ANCOVA
Secondary
Day Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the day in week 12
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 12 | 1.361 Puffs per day | Standard Error 0.139 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 12 | 1.409 Puffs per day | Standard Error 0.137 |
p-value: 0.810995% CI: [-0.437, 0.342]ANCOVA
Secondary
Day Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the day in week 2
Time frame: Week 2
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 2 | 1.24 Puffs per day | Standard Error 0.099 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 2 | 1.309 Puffs per day | Standard Error 0.096 |
p-value: 0.618995% CI: [-0.343, 0.205]ANCOVA
Secondary
Day Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the day in week 3
Time frame: Week 3
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 3 | 1.337 Puffs per day | Standard Error 0.104 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 3 | 1.41 Puffs per day | Standard Error 0.101 |
p-value: 0.619795% CI: [-0.36, 0.215]ANCOVA
Secondary
Day Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the day in week 4
Time frame: Week 4
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 4 | 1.287 Puffs per day | Standard Error 0.107 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 4 | 1.399 Puffs per day | Standard Error 0.104 |
p-value: 0.458295% CI: [-0.408, 0.184]ANCOVA
Secondary
Day Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the day in week 5
Time frame: Week 5
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 5 | 1.275 Puffs per day | Standard Error 0.11 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 5 | 1.345 Puffs per day | Standard Error 0.107 |
p-value: 0.653895% CI: [-0.376, 0.236]ANCOVA
Secondary
Day Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the day in week 6
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 6 | 1.259 Puffs per day | Standard Error 0.126 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 6 | 1.405 Puffs per day | Standard Error 0.123 |
p-value: 0.414595% CI: [-0.495, 0.205]ANCOVA
Secondary
Day Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the day in week 7
Time frame: Week 7
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 7 | 1.313 Puffs per day | Standard Error 0.116 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 7 | 1.398 Puffs per day | Standard Error 0.114 |
p-value: 0.604895% CI: [-0.408, 0.238]ANCOVA
Secondary
Day Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the day in week 8
Time frame: Week 8
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 8 | 1.301 Puffs per day | Standard Error 0.119 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 8 | 1.471 Puffs per day | Standard Error 0.117 |
p-value: 0.313795% CI: [-0.503, 0.162]ANCOVA
Secondary
Day Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the day in week 9
Time frame: Week 9
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Day Time Albuterol Use During Week 9 | 1.369 Puffs per day | Standard Error 0.12 |
| Combivent (Ipratropium/Albuterol) | Day Time Albuterol Use During Week 9 | 1.43 Puffs per day | Standard Error 0.117 |
p-value: 0.719595% CI: [-0.395, 0.273]ANCOVA
Secondary
Evening PEFR at Week 1
Weekly means for evening PEFR
Time frame: Week 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 1 | 222.89 Liters/minute | Standard Error 2.459 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 1 | 222.64 Liters/minute | Standard Error 2.352 |
p-value: 0.610595% CI: [-8.532, 5.022]ANCOVA
Secondary
Evening PEFR at Week 10
Weekly means for evening PEFR
Time frame: Week 10
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 10 | 220.46 Liters/minute | Standard Error 3.808 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 10 | 216.32 Liters/minute | Standard Error 3.649 |
p-value: 0.438895% CI: [-6.372, 14.651]ANCOVA
Secondary
Evening PEFR at Week 11
Weekly means for evening PEFR
Time frame: Week 11
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 11 | 218.35 Liters/minute | Standard Error 3.91 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 11 | 217.17 Liters/minute | Standard Error 3.724 |
p-value: 0.828895% CI: [-9.595, 11.964]ANCOVA
Secondary
Evening PEFR at Week 12
Weekly means for evening PEFR
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 12 | 219.66 Liters/minute | Standard Error 4.371 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 12 | 215.46 Liters/minute | Standard Error 4.19 |
p-value: 0.492995% CI: [-7.857, 16.264]ANCOVA
Secondary
Evening PEFR at Week 2
Weekly means for evening PEFR
Time frame: Week 2
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 2 | 221.97 Liters/minute | Standard Error 2.715 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 2 | 221.12 Liters/minute | Standard Error 2.596 |
p-value: 0.824995% CI: [-6.642, 8.326]ANCOVA
Secondary
Evening PEFR at Week 3
Weekly means for evening PEFR
Time frame: Week 3
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 3 | 221.23 Liters/minute | Standard Error 2.793 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 3 | 218.52 Liters/minute | Standard Error 2.681 |
p-value: 0.489695% CI: [-5.001, 10.421]ANCOVA
Secondary
Evening PEFR at Week 4
Weekly means for evening PEFR
Time frame: Week 4
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 4 | 221.96 Liters/minute | Standard Error 2.933 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 4 | 215.06 Liters/minute | Standard Error 2.796 |
p-value: 0.093595% CI: [-1.172, 14.968]ANCOVA
Secondary
Evening PEFR at Week 5
Weekly means for evening PEFR
Time frame: Week 5
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 5 | 217.95 Liters/minute | Standard Error 3.125 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 5 | 214.53 Liters/minute | Standard Error 2.977 |
p-value: 0.433995% CI: [-5.17, 12.007]ANCOVA
Secondary
Evening PEFR at Week 6
Weekly means for evening PEFR
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 6 | 218.45 Liters/minute | Standard Error 3.535 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 6 | 219.42 Liters/minute | Standard Error 3.382 |
p-value: 0.84595% CI: [-10.74, 8.799]ANCOVA
Secondary
Evening PEFR at Week 7
Weekly means for evening PEFR
Time frame: Week 7
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 7 | 220.98 Liters/minute | Standard Error 3.63 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 7 | 220.79 Liters/minute | Standard Error 3.468 |
p-value: 0.969695% CI: [-9.811, 10.199]ANCOVA
Secondary
Evening PEFR at Week 8
Weekly means for evening PEFR
Time frame: Week 8
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 8 | 223.33 Liters/minute | Standard Error 3.721 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 8 | 218.2 Liters/minute | Standard Error 3.553 |
p-value: 0.325295% CI: [-5.117, 15.376]ANCOVA
Secondary
Evening PEFR at Week 9
Weekly means for evening PEFR
Time frame: Week 9
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Evening PEFR at Week 9 | 221.47 Liters/minute | Standard Error 3.86 |
| Combivent (Ipratropium/Albuterol) | Evening PEFR at Week 9 | 217.41 Liters/minute | Standard Error 3.674 |
p-value: 0.45295% CI: [-6.558, 14.683]ANCOVA
Secondary
FEV1 at -10 Minutes at Week 12
Time frame: 10 minutes before dosing
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at -10 Minutes at Week 12 | 1.225 Liters | Standard Error 0.018 |
| Combivent (Ipratropium/Albuterol) | FEV1 at -10 Minutes at Week 12 | 1.119 Liters | Standard Error 0.018 |
p-value: <0.000195% CI: [0.055, 0.157]ANCOVA
Secondary
FEV1 at -10 Minutes at Week 6
Time frame: 10 minutes before dosing
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at -10 Minutes at Week 6 | 1.254 Liters | Standard Error 0.017 |
| Combivent (Ipratropium/Albuterol) | FEV1 at -10 Minutes at Week 6 | 1.108 Liters | Standard Error 0.017 |
p-value: <0.000195% CI: [0.098, 0.193]ANCOVA
Secondary
FEV1 at 15 Minutes at Week 12
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 15 Minutes at Week 12 | 1.268 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 15 Minutes at Week 12 | 1.351 Liters | Standard Error 0.019 |
p-value: 0.002395% CI: [-0.136, -0.03]ANCOVA
Secondary
FEV1 at 15 Minutes at Week 6
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 15 Minutes at Week 6 | 1.3 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 15 Minutes at Week 6 | 1.355 Liters | Standard Error 0.019 |
p-value: 0.041195% CI: [-0.108, -0.002]ANCOVA
Secondary
FEV1 at 15 Minutes on Day 1
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 15 Minutes on Day 1 | 1.214 Liters | Standard Error 0.012 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 15 Minutes on Day 1 | 1.389 Liters | Standard Error 0.011 |
p-value: <0.000195% CI: [-0.207, -0.142]ANCOVA
Secondary
FEV1 at 1 Hour at Week 12
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 1 Hour at Week 12 | 1.327 Liters | Standard Error 0.02 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 1 Hour at Week 12 | 1.41 Liters | Standard Error 0.02 |
p-value: 0.004495% CI: [-0.139, -0.026]ANCOVA
Secondary
FEV1 at 1 Hour at Week 6
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 1 Hour at Week 6 | 1.343 Liters | Standard Error 0.021 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 1 Hour at Week 6 | 1.405 Liters | Standard Error 0.021 |
p-value: 0.04195% CI: [-0.121, -0.003]ANCOVA
Secondary
FEV1 at 1 Hour on Day 1
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 1 Hour on Day 1 | 1.272 Liters | Standard Error 0.014 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 1 Hour on Day 1 | 1.455 Liters | Standard Error 0.014 |
p-value: <0.000195% CI: [-0.221, -0.143]ANCOVA
Secondary
FEV1 at 2 Hours at Week 12
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 2 Hours at Week 12 | 1.353 Liters | Standard Error 0.021 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 2 Hours at Week 12 | 1.398 Liters | Standard Error 0.02 |
p-value: 0.118295% CI: [-0.103, 0.012]ANCOVA
Secondary
FEV1 at 2 Hours at Week 6
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 2 Hours at Week 6 | 1.364 Liters | Standard Error 0.021 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 2 Hours at Week 6 | 1.382 Liters | Standard Error 0.02 |
p-value: 0.538795% CI: [-0.076, 0.04]ANCOVA
Secondary
FEV1 at 2 Hours on Day 1
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 2 Hours on Day 1 | 1.293 Least Squares Mean | Standard Error 0.014 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 2 Hours on Day 1 | 1.43 Least Squares Mean | Standard Error 0.014 |
p-value: <0.000195% CI: [-0.175, -0.097]ANCOVA
Secondary
FEV1 at 30 Minutes at Week 12
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 30 Minutes at Week 12 | 1.306 Liters | Standard Error 0.02 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 30 Minutes at Week 12 | 1.393 Liters | Standard Error 0.019 |
p-value: 0.001995% CI: [-0.142, -0.033]ANCOVA
Secondary
FEV1 at 30 Minutes at Week 6
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 30 Minutes at Week 6 | 1.328 Liters | Standard Error 0.02 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 30 Minutes at Week 6 | 1.388 Liters | Standard Error 0.02 |
p-value: 0.035495% CI: [-0.116, -0.004]ANCOVA
Secondary
FEV1 at 30 Minutes on Day 1
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 30 Minutes on Day 1 | 1.261 Liters | Standard Error 0.013 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 30 Minutes on Day 1 | 1.429 Liters | Standard Error 0.013 |
p-value: <0.000195% CI: [-0.205, -0.131]ANCOVA
Secondary
FEV1 at 3 Hours at Week 12
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 3 Hours at Week 12 | 1.353 Liters | Standard Error 0.021 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 3 Hours at Week 12 | 1.333 Liters | Standard Error 0.02 |
p-value: 0.481495% CI: [-0.037, 0.078]ANCOVA
Secondary
FEV1 at 3 Hours at Week 6
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 3 Hours at Week 6 | 1.371 Liters | Standard Error 0.021 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 3 Hours at Week 6 | 1.31 Liters | Standard Error 0.02 |
p-value: 0.037295% CI: [0.004, 0.118]ANCOVA
Secondary
FEV1 at 3 Hours on Day 1
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 3 Hours on Day 1 | 1.29 Liters | Standard Error 0.015 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 3 Hours on Day 1 | 1.375 Liters | Standard Error 0.014 |
p-value: <0.000195% CI: [-0.125, -0.044]ANCOVA
Secondary
FEV1 at 4 Hours at Week 12
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 4 Hours at Week 12 | 1.337 Liters | Standard Error 0.02 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 4 Hours at Week 12 | 1.263 Liters | Standard Error 0.019 |
p-value: 0.00895% CI: [0.019, 0.129]ANCOVA
Secondary
FEV1 at 4 Hours at Week 6
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 4 Hours at Week 6 | 1.369 Liters | Standard Error 0.02 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 4 Hours at Week 6 | 1.247 Liters | Standard Error 0.02 |
p-value: <0.000195% CI: [0.066, 0.177]ANCOVA
Secondary
FEV1 at 4 Hours on Day 1
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 4 Hours on Day 1 | 1.284 Liters | Standard Error 0.015 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 4 Hours on Day 1 | 1.319 Liters | Standard Error 0.015 |
p-value: 0.099795% CI: [-0.076, 0.007]ANCOVA
Secondary
FEV1 at 6 Hours at Week 12
Time frame: 6 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 6 Hours at Week 12 | 1.318 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 6 Hours at Week 12 | 1.182 Liters | Standard Error 0.019 |
p-value: <0.000195% CI: [0.082, 0.19]ANCOVA
Secondary
FEV1 at 6 Hours at Week 6
Time frame: 6 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 6 Hours at Week 6 | 1.33 Liters | Standard Error 0.019 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 6 Hours at Week 6 | 1.168 Liters | Standard Error 0.019 |
p-value: <0.000195% CI: [0.108, 0.216]ANCOVA
Secondary
FEV1 at 6 Hours on Day 1
Time frame: 6 hours
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FEV1 at 6 Hours on Day 1 | 1.269 Liters | Standard Error 0.016 |
| Combivent (Ipratropium/Albuterol) | FEV1 at 6 Hours on Day 1 | 1.233 Liters | Standard Error 0.015 |
p-value: 0.10195% CI: [-0.007, 0.08]ANCOVA
Secondary
FVC at -10 Minutes at Week 12
Time frame: 10 minutes before dosing
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at -10 Minutes at Week 12 | 2.967 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at -10 Minutes at Week 12 | 2.792 Liters | Standard Error 0.038 |
p-value: 0.001595% CI: [0.067, 0.283]ANCOVA
Secondary
FVC at -10 Minutes at Week 6
Time frame: 10 minutes before dosing
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at -10 Minutes at Week 6 | 3 Liters | Standard Error 0.036 |
| Combivent (Ipratropium/Albuterol) | FVC at -10 Minutes at Week 6 | 2.722 Liters | Standard Error 0.035 |
p-value: <0.000195% CI: [0.178, 0.379]ANCOVA
Secondary
FVC at 15 Minutes at Week 12
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 15 Minutes at Week 12 | 3.069 Liters | Standard Error 0.037 |
| Combivent (Ipratropium/Albuterol) | FVC at 15 Minutes at Week 12 | 3.263 Liters | Standard Error 0.036 |
p-value: 0.000295% CI: [-0.296, -0.091]ANCOVA
Secondary
FVC at 15 Minutes at Week 6
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 15 Minutes at Week 6 | 3.09 Liters | Standard Error 0.037 |
| Combivent (Ipratropium/Albuterol) | FVC at 15 Minutes at Week 6 | 3.279 Liters | Standard Error 0.036 |
p-value: 0.000495% CI: [-0.293, -0.086]ANCOVA
Secondary
FVC at 15 Minutes on Day 1
Time frame: 15 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 15 Minutes on Day 1 | 2.938 Liters | Standard Error 0.036 |
| Combivent (Ipratropium/Albuterol) | FVC at 15 Minutes on Day 1 | 3.308 Liters | Standard Error 0.035 |
p-value: <0.000195% CI: [-0.449, -0.29]ANCOVA
Secondary
FVC at 1 Hour at Week 12
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 1 Hour at Week 12 | 3.177 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 1 Hour at Week 12 | 3.375 Liters | Standard Error 0.039 |
p-value: 0.000695% CI: [-0.309, -0.086]ANCOVA
Secondary
FVC at 1 Hour at Week 6
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 1 Hour at Week 6 | 3.206 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 1 Hour at Week 6 | 3.388 Liters | Standard Error 0.039 |
p-value: 0.01295% CI: [-0.293, -0.072]ANCOVA
Secondary
FVC at 1 Hour on Day 1
Time frame: 1 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 1 Hour on Day 1 | 3.087 Liters | Standard Error 0.033 |
| Combivent (Ipratropium/Albuterol) | FVC at 1 Hour on Day 1 | 3.444 Liters | Standard Error 0.033 |
p-value: <0.000195% CI: [-0.451, -0.264]ANCOVA
Secondary
FVC at 2 Hours at Week 12
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 2 Hours at Week 12 | 3.231 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 2 Hours at Week 12 | 3.328 Liters | Standard Error 0.04 |
p-value: 0.089695% CI: [-0.21, 0.015]ANCOVA
Secondary
FVC at 2 Hours at Week 6
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 2 Hours at Week 6 | 3.227 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at 2 Hours at Week 6 | 3.338 Liters | Standard Error 0.038 |
p-value: 0.04495% CI: [-0.219, 0.003]ANCOVA
Secondary
FVC at 2 Hours on Day 1
Time frame: 2 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 2 Hours on Day 1 | 3.103 Liters | Standard Error 0.033 |
| Combivent (Ipratropium/Albuterol) | FVC at 2 Hours on Day 1 | 3.388 Liters | Standard Error 0.032 |
p-value: <0.000195% CI: [-0.376, -0.194]ANCOVA
Secondary
FVC at 30 Minutes at Week 12
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 30 Minutes at Week 12 | 3.143 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at 30 Minutes at Week 12 | 3.358 Liters | Standard Error 0.038 |
p-value: <0.000195% CI: [-0.323, -0.108]ANCOVA
Secondary
FVC at 30 Minutes at Week 6
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 30 Minutes at Week 6 | 3.158 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at 30 Minutes at Week 6 | 3.362 Liters | Standard Error 0.039 |
p-value: 0.000395% CI: [-0.314, -0.095]ANCOVA
Secondary
FVC at 30 Minutes on Day 1
Time frame: 30 minutes
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 30 Minutes on Day 1 | 3.044 Liters | Standard Error 0.03 |
| Combivent (Ipratropium/Albuterol) | FVC at 30 Minutes on Day 1 | 3.4 Liters | Standard Error 0.03 |
p-value: <0.000195% CI: [-0.44, -0.272]ANCOVA
Secondary
FVC at 3 Hours at Week 12
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 3 Hours at Week 12 | 3.226 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 3 Hours at Week 12 | 3.218 Liters | Standard Error 0.039 |
p-value: 0.893795% CI: [-0.103, 0.118]ANCOVA
Secondary
FVC at 3 Hours at Week 6
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 3 Hours at Week 6 | 3.235 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at 3 Hours at Week 6 | 3.185 Liters | Standard Error 0.038 |
p-value: 0.363495% CI: [-0.058, 0.158]ANCOVA
Secondary
FVC at 3 Hours on Day 1
Time frame: 3 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 3 Hours on Day 1 | 3.091 Liters | Standard Error 0.033 |
| Combivent (Ipratropium/Albuterol) | FVC at 3 Hours on Day 1 | 3.261 Liters | Standard Error 0.032 |
p-value: 0.000395% CI: [-0.261, -0.079]ANCOVA
Secondary
FVC at 4 Hours at Week 12
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 4 Hours at Week 12 | 3.199 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 4 Hours at Week 12 | 3.074 Liters | Standard Error 0.039 |
p-value: 0.026995% CI: [0.014, 0.236]ANCOVA
Secondary
FVC at 4 Hours at Week 6
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 4 Hours at Week 6 | 3.23 Liters | Standard Error 0.039 |
| Combivent (Ipratropium/Albuterol) | FVC at 4 Hours at Week 6 | 3.068 Liters | Standard Error 0.038 |
p-value: 0.003295% CI: [0.055, 0.27]ANCOVA
Secondary
FVC at 4 Hours on Day 1
Time frame: 4 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 4 Hours on Day 1 | 3.087 Liters | Standard Error 0.034 |
| Combivent (Ipratropium/Albuterol) | FVC at 4 Hours on Day 1 | 3.136 Liters | Standard Error 0.033 |
p-value: 0.299295% CI: [-0.143, 0.044]ANCOVA
Secondary
FVC at 6 Hours at Week 12
Time frame: 6 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 6 Hours at Week 12 | 3.155 Liters | Standard Error 0.04 |
| Combivent (Ipratropium/Albuterol) | FVC at 6 Hours at Week 12 | 2.932 Liters | Standard Error 0.04 |
p-value: 0.000195% CI: [0.111, 0.335]ANCOVA
Secondary
FVC at 6 Hours at Week 6
Time frame: 6 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 6 Hours at Week 6 | 3.190 Liters | Standard Error 0.037 |
| Combivent (Ipratropium/Albuterol) | FVC at 6 Hours at Week 6 | 2.914 Liters | Standard Error 0.036 |
p-value: <0.000195% CI: [0.173, 0.378]ANCOVA
Secondary
FVC at 6 Hours on Day 1
Time frame: 6 hour
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | FVC at 6 Hours on Day 1 | 3.053 Liters | Standard Error 0.034 |
| Combivent (Ipratropium/Albuterol) | FVC at 6 Hours on Day 1 | 2.972 Liters | Standard Error 0.034 |
p-value: 0.098495% CI: [-0.015, 0.177]ANCOVA
Secondary
Morning Peak Expiratory Flow Rate (PEFR) at Week 1
Time frame: Week 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Peak Expiratory Flow Rate (PEFR) at Week 1 | 205.8 Liters/minute | Standard Error 2.1 |
| Combivent (Ipratropium/Albuterol) | Morning Peak Expiratory Flow Rate (PEFR) at Week 1 | 195.1 Liters/minute | Standard Error 2.059 |
p-value: 0.000495% CI: [4.836, 16.56]ANCOVA
Secondary
Morning PEFR at Week 10
Weekly means for morning PEFR
Time frame: Week 10
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 10 | 204.83 Liters/minute | Standard Error 3.608 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 10 | 193.23 Liters/minute | Standard Error 3.568 |
p-value: 0.024895% CI: [1.483, 21.71]ANCOVA
Secondary
Morning PEFR at Week 11
Weekly means for morning PEFR
Time frame: Week 11
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 11 | 206.47 Liters/minute | Standard Error 3.607 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 11 | 195.47 Liters/minute | Standard Error 3.542 |
p-value: 0.032595% CI: [0.924, 21.079]ANCOVA
Secondary
Morning PEFR at Week 12
Weekly means for morning PEFR
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 12 | 206.52 Liters/minute | Standard Error 4.408 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 12 | 192.44 Liters/minute | Standard Error 3.996 |
p-value: 0.015395% CI: [2.726, 25.422]ANCOVA
Secondary
Morning PEFR at Week 2
Weekly means for morning PEFR
Time frame: Week 2
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 2 | 206.07 Liters/minute | Standard Error 2.594 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 2 | 194.81 Liters/minute | Standard Error 2.516 |
p-value: 0.002395% CI: [4.055, 18.458]ANCOVA
Secondary
Morning PEFR at Week 3
Weekly means for morning PEFR
Time frame: Week 3
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 3 | 206.61 Liters/minute | Standard Error 2.816 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 3 | 193.83 Liters/minute | Standard Error 2.742 |
p-value: 0.001595% CI: [4.942, 20.602]ANCOVA
Secondary
Morning PEFR at Week 4
Weekly means for morning PEFR
Time frame: Week 4
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 4 | 206.76 Liters/minute | Standard Error 2.959 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 4 | 193.19 Liters/minute | Standard Error 2.88 |
p-value: 0.001395% CI: [5.342, 21.795]ANCOVA
Secondary
Morning PEFR at Week 5
Weekly means for morning PEFR
Time frame: Week 5
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 5 | 205.6 Liters/minute | Standard Error 3.012 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 5 | 193.55 Liters/minute | Standard Error 2.932 |
p-value: 0.00595% CI: [3.676, 20.428]ANCOVA
Secondary
Morning PEFR at Week 6
Weekly means for morning PEFR
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 6 | 206.49 Liters/minute | Standard Error 3.236 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 6 | 195.38 Liters/minute | Standard Error 3.158 |
p-value: 0.015995% CI: [2.095, 20.119]ANCOVA
Secondary
Morning PEFR at Week 7
Weekly means for morning PEFR
Time frame: Week 7
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 7 | 208.72 Liters/minute | Standard Error 3.377 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 7 | 197.66 Liters/minute | Standard Error 3.326 |
p-value: 0.021995% CI: [1.613, 20.501]ANCOVA
Secondary
Morning PEFR at Week 8
Weekly means for morning PEFR
Time frame: Week 8
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 8 | 208.88 Liters/minute | Standard Error 3.385 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 8 | 195.22 Liters/minute | Standard Error 3.315 |
p-value: 0.004895% CI: [4.207, 23.104]ANCOVA
Secondary
Morning PEFR at Week 9
Weekly means for morning PEFR
Time frame: Week 9
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning PEFR at Week 9 | 208.97 Liters/minute | Standard Error 3.621 |
| Combivent (Ipratropium/Albuterol) | Morning PEFR at Week 9 | 194.74 Liters/minute | Standard Error 3.531 |
p-value: 0.005895% CI: [4.153, 24.31]ANCOVA
Secondary
Night Time Albuterol Use During Week 1
Time frame: Week 1
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 1 | 3.493 Puffs per night | Standard Error 0.259 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 1 | 2.966 Puffs per night | Standard Error 0.248 |
p-value: 0.147195% CI: [-0.186, 1.24]ANCOVA
Secondary
Night Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the night in week 10
Time frame: Week 10
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 10 | 3.199 Puffs per night | Standard Error 0.203 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 10 | 2.909 Puffs per night | Standard Error 0.196 |
p-value: 0.309195% CI: [-0.271, 0.852]ANCOVA
Secondary
Night Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the night in week 11
Time frame: Week 11
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 11 | 3.224 Puffs per night | Standard Error 0.214 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 11 | 2.907 Puffs per night | Standard Error 0.205 |
p-value: 0.291195% CI: [-0.273, 0.907]ANCOVA
Secondary
Night Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the night in week 12
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 12 | 3.178 Puffs per night | Standard Error 0.238 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 12 | 3.069 Puffs per night | Standard Error 0.229 |
p-value: 0.745895% CI: [-0.549, 0.766]ANCOVA
Secondary
Night Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the night in week 2
Time frame: Week 2
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 2 | 3.269 Puffs per night | Standard Error 0.19 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 2 | 3.004 Puffs per night | Standard Error 0.182 |
p-value: 0.319295% CI: [-0.258, 0.788]ANCOVA
Secondary
Night Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the night in week 3
Time frame: Week 3
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 3 | 3.282 Puffs per night | Standard Error 0.187 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 3 | 2.931 Puffs per night | Standard Error 0.18 |
p-value: 0.18295% CI: [-0.165, 0.867]ANCOVA
Secondary
Night Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the night in week 4
Time frame: Week 4
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 4 | 3.285 Puffs per night | Standard Error 0.193 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 4 | 2.921 Puffs per night | Standard Error 0.184 |
p-value: 0.177795% CI: [-0.166, 0.893]ANCOVA
Secondary
Night Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the night in week 5
Time frame: Week 5
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 5 | 3.152 Puffs per night | Standard Error 0.194 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 5 | 2.789 Puffs per night | Standard Error 0.185 |
p-value: 0.180595% CI: [-0.169, 0.895]ANCOVA
Secondary
Night Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the night in week 6
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 6 | 3.178 Puffs per night | Standard Error 0.197 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 6 | 2.806 Puffs per night | Standard Error 0.188 |
p-value: 0.177795% CI: [-0.17, 0.913]ANCOVA
Secondary
Night Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the night in week 7
Time frame: Week 7
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 7 | 3.156 Puffs per night | Standard Error 0.201 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 7 | 2.966 Puffs per night | Standard Error 0.193 |
p-value: 0.572595% CI: [-0.395, 0.714]ANCOVA
Secondary
Night Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the night in week 8
Time frame: Week 8
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 8 | 3.104 Puffs per night | Standard Error 0.207 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 8 | 2.983 Puffs per night | Standard Error 0.198 |
p-value: 0.676595% CI: [-0.449, 0.69]ANCOVA
Secondary
Night Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the night in week 9
Time frame: Week 9
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Night Time Albuterol Use During Week 9 | 3.254 Puffs per night | Standard Error 0.208 |
| Combivent (Ipratropium/Albuterol) | Night Time Albuterol Use During Week 9 | 3.006 Puffs per night | Standard Error 0.198 |
p-value: 0.394395% CI: [-0.323, 0.818]ANCOVA
Secondary
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Patient Global Evaluation | 4.273 Units on a scale | Standard Error 0.081 |
| Combivent (Ipratropium/Albuterol) | Patient Global Evaluation | 4.069 Units on a scale | Standard Error 0.079 |
p-value: 0.075495% CI: [-0.021, 0.429]ANCOVA
Secondary
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Patient Global Evaluation | 4.49 Units on a scale | Standard Error 0.1 |
| Combivent (Ipratropium/Albuterol) | Patient Global Evaluation | 4.239 Units on a scale | Standard Error 0.098 |
p-value: 0.076595% CI: [-0.027, 0.528]ANCOVA
Secondary
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time frame: Week 6
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Physician Global Evaluation | 4.867 Units on a scale | Standard Error 0.076 |
| Combivent (Ipratropium/Albuterol) | Physician Global Evaluation | 4.716 Units on a scale | Standard Error 0.075 |
p-value: 0.16395% CI: [-0.061, 0.363]ANCOVA
Secondary
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Time frame: Week 12
Population: Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Physician Global Evaluation | 5.057 Units on a scale | Standard Error 0.076 |
| Combivent (Ipratropium/Albuterol) | Physician Global Evaluation | 4.772 Units on a scale | Standard Error 0.074 |
p-value: 0.008595% CI: [0.073, 0.496]ANCOVA