Asthma
Conditions
Brief summary
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion\_Criteria: 1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg) 2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial 3. Male or female outpatients with at least 18 years of age, but not older than 65 years 4. Patients must have a documented history of asthma 5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of \<10 pack-years 6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent Exclusion\_Criteria: 1. Patients with a significant disease other than asthma 2. Patients with a recent history (i.e., six months or less) of myocardial infarction 3. Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year 4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) 7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis 8. Patients with known active tuberculosis 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial | baseline and after 16 weeks of treatment | Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Rate in Conjunction With Spirometry at Visit 4 | After 12 weeks of treatment | Pulse rate collected in conjunction with spirometry at 12 weeks |
| Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value |
| Mean Weekly Morning Peak Expiratory Flow at Week 4 | After 4 weeks of treatment | Mean weekly morning peak expiratory flow at week 4, pre-dose |
| Mean Weekly Morning Peak Expiratory Flow at Week 8 | After 8 weeks of treatment | Mean weekly morning peak expiratory flow at week 8, pre-dose |
| Mean Weekly Morning Peak Expiratory Flow at Week 12 | After 12 weeks of treatment | Mean weekly morning peak expiratory flow at week 12, pre-dose |
| Mean Weekly Morning Peak Expiratory Flow at Week 16 | After 16 weeks of treatment | Mean weekly morning peak expiratory flow at week 16, pre-dose |
| Mean Weekly Evening Peak Expiratory Flow at Week 4 | After 4 weeks of treatment | Mean weekly evening peak expiratory flow at week 4, pre-dose |
| Mean Weekly Evening Peak Expiratory Flow at Week 8 | After 8 weeks of treatment | Mean weekly evening peak expiratory flow at week 8, pre-dose |
| Mean Weekly Evening Peak Expiratory Flow at Week 12 | After 12 weeks of treatment | Mean weekly evening peak expiratory flow at week 12, pre-dose |
| Mean Weekly Evening Peak Expiratory Flow at Week 16 | After 16 weeks of treatment | Mean weekly evening peak expiratory flow at week 16, pre-dose |
| Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 | After 4 weeks of treatment | Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose |
| Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 | After 8 weeks of treatment | Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose |
| Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 | After 12 weeks of treatment | Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose |
| Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 | After 16 weeks of treatment | Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose |
| Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 | After 4 weeks of treatment | Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose |
| Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 | After 8 weeks of treatment | Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose |
| Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 | After 12 weeks of treatment | Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose |
| Pulse Rate in Conjunction With Spirometry at Visit 3 | After 6 weeks of treatment | Pulse rate collected in conjunction with spirometry at 6 weeks |
| Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 | After 16 weeks of treatment | Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose |
| Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4 | After 4 weeks of treatment | Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8 | After 8 weeks of treatment | Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12 | After 12 weeks of treatment | Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value |
| Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16 | After 16 weeks of treatment | Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value |
| Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 | After 6 weeks of treatment | Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment |
| Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 | After 12 weeks of treatment | Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment |
| Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 | After 16 weeks of treatment | Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment |
| Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 | After 6 weeks of treatment | Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment |
| Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 | After 12 weeks of treatment | Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment |
| Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 | After 16 weeks of treatment | Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment |
| Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 | After 6 weeks of treatment | Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value |
| Mini-AQLQ Overall Score at Visit 4 | After 12 weeks of treatment | Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value |
| Mini-AQLQ Overall Score at Visit 5 | After 16 weeks of treatment | Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value |
| Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 | After 6 weeks of treatment | Systolic blood pressure collected in conjunction with spirometry at 6 weeks |
| Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 | After 12 weeks of treatment | Systolic blood pressure collected in conjunction with spirometry at 12 weeks |
| Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 | After 16 weeks of treatment | Systolic blood pressure collected in conjunction with spirometry at 16 weeks |
| Pulse Rate in Conjunction With Spirometry at Visit 5 | After 16 weeks of treatment | Pulse rate collected in conjunction with spirometry at 16 weeks |
| Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 | After 12 weeks of treatment | Diastolic blood pressure collected in conjunction with spirometry at 12 weeks |
| Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 | After 16 weeks of treatment | Diastolic blood pressure collected in conjunction with spirometry at 16 weeks |
| Mean PEF Variability at Week 4 | After 4 weeks of treatment | PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100% |
| Mean PEF Variability at Week 8 | After 8 weeks of treatment | PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100% |
| Mean PEF Variability at Week 12 | After 12 weeks of treatment | PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100% |
| Mean PEF Variability at Week 16 | After 16 weeks of treatment | PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100% |
| Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 | After 6 weeks of treatment | Diastolic blood pressure collected in conjunction with spirometry at 6 weeks |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Russia, Slovakia, South Africa, Spain, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium Tiotropium inhalation solution, 5mcg once daily PM | 128 |
| Salmeterol Salmeterol Metered Aerosol, 50mcg twice daily | 134 |
| Placebo Matching Placebo | 126 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Other | 1 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Tiotropium | Salmeterol | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 12.6 | 42.3 years STANDARD_DEVIATION 13.4 | 44.0 years STANDARD_DEVIATION 11.9 | 43.3 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 82 Participants | 83 Participants | 75 Participants | 240 Participants |
| Sex: Female, Male Male | 46 Participants | 51 Participants | 51 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 128 | 18 / 134 | 25 / 126 |
| serious Total, serious adverse events | 2 / 128 | 7 / 134 | 1 / 126 |
Outcome results
Primary
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit
Time frame: baseline and after 16 weeks of treatment
Population: The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial | -3.93 L/min | Standard Error 4.873 |
| Salmeterol | Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial | -3.15 L/min | Standard Error 4.64 |
| Placebo | Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial | -24.63 L/min | Standard Error 4.835 |
Secondary
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
Time frame: After 6 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 78.62 mmHg | Standard Deviation 9.26 |
| Salmeterol | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 77.62 mmHg | Standard Deviation 8.74 |
| Placebo | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 79.34 mmHg | Standard Deviation 8.37 |
Secondary
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
Time frame: After 12 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 77.88 mmHg | Standard Deviation 9.93 |
| Salmeterol | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 77.22 mmHg | Standard Deviation 9.23 |
| Placebo | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 78.29 mmHg | Standard Deviation 8.04 |
Secondary
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
Time frame: After 16 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 79.23 mmHg | Standard Deviation 9.35 |
| Salmeterol | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 77.61 mmHg | Standard Deviation 7.92 |
| Placebo | Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 78.38 mmHg | Standard Deviation 9.38 |
Secondary
Mean PEF Variability at Week 12
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean PEF Variability at Week 12 | 11.735 ratio expressed in percent | Standard Error 0.654 |
| Salmeterol | Mean PEF Variability at Week 12 | 11.320 ratio expressed in percent | Standard Error 0.625 |
| Placebo | Mean PEF Variability at Week 12 | 11.257 ratio expressed in percent | Standard Error 0.648 |
Secondary
Mean PEF Variability at Week 16
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean PEF Variability at Week 16 | 11.742 ratio expressed in percent | Standard Error 0.656 |
| Salmeterol | Mean PEF Variability at Week 16 | 10.793 ratio expressed in percent | Standard Error 0.627 |
| Placebo | Mean PEF Variability at Week 16 | 12.305 ratio expressed in percent | Standard Error 0.65 |
Secondary
Mean PEF Variability at Week 4
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean PEF Variability at Week 4 | 12.043 ratio expressed in percent | Standard Error 0.611 |
| Salmeterol | Mean PEF Variability at Week 4 | 10.547 ratio expressed in percent | Standard Error 0.584 |
| Placebo | Mean PEF Variability at Week 4 | 12.085 ratio expressed in percent | Standard Error 0.606 |
Secondary
Mean PEF Variability at Week 8
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean PEF Variability at Week 8 | 13.377 ratio expressed in percent | Standard Error 0.695 |
| Salmeterol | Mean PEF Variability at Week 8 | 11.252 ratio expressed in percent | Standard Error 0.664 |
| Placebo | Mean PEF Variability at Week 8 | 12.964 ratio expressed in percent | Standard Error 0.689 |
Secondary
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 | 2.31 L | Standard Error 0.032 |
| Salmeterol | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 | 2.299 L | Standard Error 0.03 |
| Placebo | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 | 2.231 L | Standard Error 0.032 |
Secondary
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 | 2.343 L | Standard Error 0.031 |
| Salmeterol | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 | 2.291 L | Standard Error 0.029 |
| Placebo | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 | 2.215 L | Standard Error 0.031 |
Secondary
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 | 2.369 L | Standard Error 0.029 |
| Salmeterol | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 | 2.318 L | Standard Error 0.028 |
| Placebo | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 | 2.25 L | Standard Error 0.029 |
Secondary
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 | 2.32 L | Standard Error 0.03 |
| Salmeterol | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 | 2.301 L | Standard Error 0.029 |
| Placebo | Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 | 2.239 L | Standard Error 0.03 |
Secondary
Mean Weekly Evening Peak Expiratory Flow at Week 12
Mean weekly evening peak expiratory flow at week 12, pre-dose
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Peak Expiratory Flow at Week 12 | 366.282 L/min | Standard Error 4.851 |
| Salmeterol | Mean Weekly Evening Peak Expiratory Flow at Week 12 | 362.01 L/min | Standard Error 4.617 |
| Placebo | Mean Weekly Evening Peak Expiratory Flow at Week 12 | 344.291 L/min | Standard Error 4.81 |
Secondary
Mean Weekly Evening Peak Expiratory Flow at Week 16
Mean weekly evening peak expiratory flow at week 16, pre-dose
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Peak Expiratory Flow at Week 16 | 363.657 L/min | Standard Error 5.242 |
| Salmeterol | Mean Weekly Evening Peak Expiratory Flow at Week 16 | 360.304 L/min | Standard Error 4.99 |
| Placebo | Mean Weekly Evening Peak Expiratory Flow at Week 16 | 340.099 L/min | Standard Error 5.198 |
Secondary
Mean Weekly Evening Peak Expiratory Flow at Week 4
Mean weekly evening peak expiratory flow at week 4, pre-dose
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Peak Expiratory Flow at Week 4 | 374.496 L/min | Standard Error 4.249 |
| Salmeterol | Mean Weekly Evening Peak Expiratory Flow at Week 4 | 366.219 L/min | Standard Error 4.045 |
| Placebo | Mean Weekly Evening Peak Expiratory Flow at Week 4 | 348.344 L/min | Standard Error 4.213 |
Secondary
Mean Weekly Evening Peak Expiratory Flow at Week 8
Mean weekly evening peak expiratory flow at week 8, pre-dose
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Evening Peak Expiratory Flow at Week 8 | 368.758 L/min | Standard Error 4.78 |
| Salmeterol | Mean Weekly Evening Peak Expiratory Flow at Week 8 | 359.586 L/min | Standard Error 4.551 |
| Placebo | Mean Weekly Evening Peak Expiratory Flow at Week 8 | 345.299 L/min | Standard Error 4.74 |
Secondary
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 | 2.256 L | Standard Error 0.03 |
| Salmeterol | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 | 2.254 L | Standard Error 0.029 |
| Placebo | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 | 2.156 L | Standard Error 0.03 |
Secondary
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 | 2.3 L | Standard Error 0.03 |
| Salmeterol | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 | 2.278 L | Standard Error 0.028 |
| Placebo | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 | 2.188 L | Standard Error 0.029 |
Secondary
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 | 2.301 L | Standard Error 0.026 |
| Salmeterol | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 | 2.316 L | Standard Error 0.024 |
| Placebo | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 | 2.161 L | Standard Error 0.025 |
Secondary
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 | 2.254 L | Standard Error 0.028 |
| Salmeterol | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 | 2.287 L | Standard Error 0.027 |
| Placebo | Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 | 2.164 L | Standard Error 0.028 |
Secondary
Mean Weekly Morning Peak Expiratory Flow at Week 12
Mean weekly morning peak expiratory flow at week 12, pre-dose
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Peak Expiratory Flow at Week 12 | 359.05 L/min | Standard Error 4.885 |
| Salmeterol | Mean Weekly Morning Peak Expiratory Flow at Week 12 | 351.3 L/min | Standard Error 4.652 |
| Placebo | Mean Weekly Morning Peak Expiratory Flow at Week 12 | 332.808 L/min | Standard Error 4.847 |
Secondary
Mean Weekly Morning Peak Expiratory Flow at Week 16
Mean weekly morning peak expiratory flow at week 16, pre-dose
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Peak Expiratory Flow at Week 16 | 355.619 L/min | Standard Error 4.868 |
| Salmeterol | Mean Weekly Morning Peak Expiratory Flow at Week 16 | 355.799 L/min | Standard Error 4.636 |
| Placebo | Mean Weekly Morning Peak Expiratory Flow at Week 16 | 334.525 L/min | Standard Error 4.831 |
Secondary
Mean Weekly Morning Peak Expiratory Flow at Week 4
Mean weekly morning peak expiratory flow at week 4, pre-dose
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Peak Expiratory Flow at Week 4 | 360.695 L/min | Standard Error 4.244 |
| Salmeterol | Mean Weekly Morning Peak Expiratory Flow at Week 4 | 359.762 L/min | Standard Error 4.041 |
| Placebo | Mean Weekly Morning Peak Expiratory Flow at Week 4 | 335.515 L/min | Standard Error 4.211 |
Secondary
Mean Weekly Morning Peak Expiratory Flow at Week 8
Mean weekly morning peak expiratory flow at week 8, pre-dose
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Morning Peak Expiratory Flow at Week 8 | 355.42 L/min | Standard Error 4.646 |
| Salmeterol | Mean Weekly Morning Peak Expiratory Flow at Week 8 | 350.53 L/min | Standard Error 4.424 |
| Placebo | Mean Weekly Morning Peak Expiratory Flow at Week 8 | 330.193 L/min | Standard Error 4.61 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12 | 1.539 Unit on a scale | Standard Error 0.051 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12 | 1.505 Unit on a scale | Standard Error 0.05 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12 | 1.572 Unit on a scale | Standard Error 0.052 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16 | 1.528 Unit on a scale | Standard Error 0.057 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16 | 1.515 Unit on a scale | Standard Error 0.056 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16 | 1.669 Unit on a scale | Standard Error 0.057 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4 | 1.679 Unit on a scale | Standard Error 0.048 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4 | 1.605 Unit on a scale | Standard Error 0.046 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4 | 1.652 Unit on a scale | Standard Error 0.049 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8 | 1.519 Unit on a scale | Standard Error 0.05 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8 | 1.56 Unit on a scale | Standard Error 0.047 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8 | 1.575 Unit on a scale | Standard Error 0.05 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12 | 1.203 Unit on a scale | Standard Error 0.031 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12 | 1.194 Unit on a scale | Standard Error 0.03 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12 | 1.224 Unit on a scale | Standard Error 0.032 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16 | 1.196 Unit on a scale | Standard Error 0.034 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16 | 1.135 Unit on a scale | Standard Error 0.033 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16 | 1.185 Unit on a scale | Standard Error 0.034 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4 | 1.267 Unit on a scale | Standard Error 0.029 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4 | 1.22 Unit on a scale | Standard Error 0.027 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4 | 1.232 Unit on a scale | Standard Error 0.029 |
Secondary
Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8 | 1.182 Unit on a scale | Standard Error 0.027 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8 | 1.176 Unit on a scale | Standard Error 0.025 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8 | 1.21 Unit on a scale | Standard Error 0.027 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12 | 1.458 Unit on a scale | Standard Error 0.045 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12 | 1.436 Unit on a scale | Standard Error 0.044 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12 | 1.52 Unit on a scale | Standard Error 0.046 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16 | 1.446 Unit on a scale | Standard Error 0.049 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16 | 1.415 Unit on a scale | Standard Error 0.047 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16 | 1.593 Unit on a scale | Standard Error 0.049 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4 | 1.549 Unit on a scale | Standard Error 0.041 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4 | 1.514 Unit on a scale | Standard Error 0.039 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4 | 1.583 Unit on a scale | Standard Error 0.041 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8 | 1.475 Unit on a scale | Standard Error 0.041 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8 | 1.478 Unit on a scale | Standard Error 0.039 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8 | 1.545 Unit on a scale | Standard Error 0.042 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12 | 1.57 Unit on a scale | Standard Error 0.048 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12 | 1.482 Unit on a scale | Standard Error 0.047 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12 | 1.62 Unit on a scale | Standard Error 0.049 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16 | 1.623 Unit on a scale | Standard Error 0.057 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16 | 1.482 Unit on a scale | Standard Error 0.055 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16 | 1.691 Unit on a scale | Standard Error 0.057 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4 | 1.699 Unit on a scale | Standard Error 0.045 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4 | 1.627 Unit on a scale | Standard Error 0.043 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4 | 1.735 Unit on a scale | Standard Error 0.045 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8 | 1.557 Unit on a scale | Standard Error 0.047 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8 | 1.571 Unit on a scale | Standard Error 0.045 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8 | 1.643 Unit on a scale | Standard Error 0.048 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12 | 1.572 Unit on a scale | Standard Error 0.05 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12 | 1.495 Unit on a scale | Standard Error 0.049 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12 | 1.682 Unit on a scale | Standard Error 0.051 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16 | 1.609 Unit on a scale | Standard Error 0.054 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16 | 1.476 Unit on a scale | Standard Error 0.053 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16 | 1.711 Unit on a scale | Standard Error 0.054 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4 | 1.735 Unit on a scale | Standard Error 0.045 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4 | 1.637 Unit on a scale | Standard Error 0.043 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4 | 1.744 Unit on a scale | Standard Error 0.045 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8 | 1.603 Unit on a scale | Standard Error 0.046 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8 | 1.569 Unit on a scale | Standard Error 0.043 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8 | 1.699 Unit on a scale | Standard Error 0.046 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 4 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4 | 1.612 Unit on a scale | Standard Error 0.041 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4 | 1.486 Unit on a scale | Standard Error 0.038 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4 | 1.615 Unit on a scale | Standard Error 0.041 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12 | 1.519 Unit on a scale | Standard Error 0.046 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12 | 1.436 Unit on a scale | Standard Error 0.045 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12 | 1.542 Unit on a scale | Standard Error 0.047 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16 | 1.536 Unit on a scale | Standard Error 0.052 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16 | 1.461 Unit on a scale | Standard Error 0.051 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16 | 1.647 Unit on a scale | Standard Error 0.052 |
Secondary
Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Time frame: After 8 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8 | 1.504 Unit on a scale | Standard Error 0.043 |
| Salmeterol | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8 | 1.481 Unit on a scale | Standard Error 0.041 |
| Placebo | Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8 | 1.613 Unit on a scale | Standard Error 0.043 |
Secondary
Mini-AQLQ Overall Score at Visit 4
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mini-AQLQ Overall Score at Visit 4 | 5.233 Unit on a scale | Standard Error 0.066 |
| Salmeterol | Mini-AQLQ Overall Score at Visit 4 | 5.399 Unit on a scale | Standard Error 0.063 |
| Placebo | Mini-AQLQ Overall Score at Visit 4 | 5.078 Unit on a scale | Standard Error 0.066 |
Secondary
Mini-AQLQ Overall Score at Visit 5
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mini-AQLQ Overall Score at Visit 5 | 5.305 Unit on a scale | Standard Error 0.068 |
| Salmeterol | Mini-AQLQ Overall Score at Visit 5 | 5.454 Unit on a scale | Standard Error 0.064 |
| Placebo | Mini-AQLQ Overall Score at Visit 5 | 5.214 Unit on a scale | Standard Error 0.067 |
Secondary
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Time frame: After 6 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 | 5.050 Unit on a scale | Standard Error 0.067 |
| Salmeterol | Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 | 5.259 Unit on a scale | Standard Error 0.064 |
| Placebo | Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 | 5.097 Unit on a scale | Standard Error 0.067 |
Secondary
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment
Time frame: After 6 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 | 2.471 L | Standard Error 0.031 |
| Salmeterol | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 | 2.401 L | Standard Error 0.03 |
| Placebo | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 | 2.299 L | Standard Error 0.031 |
Secondary
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 | 2.467 L | Standard Error 0.031 |
| Salmeterol | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 | 2.442 L | Standard Error 0.03 |
| Placebo | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 | 2.266 L | Standard Error 0.031 |
Secondary
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 | 2.439 L | Standard Error 0.03 |
| Salmeterol | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 | 2.457 L | Standard Error 0.029 |
| Placebo | Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 | 2.29 L | Standard Error 0.03 |
Secondary
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
Time frame: After 6 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 | 3.531 L | Standard Error 0.034 |
| Salmeterol | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 | 3.441 L | Standard Error 0.033 |
| Placebo | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 | 3.367 L | Standard Error 0.034 |
Secondary
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 | 3.509 L | Standard Error 0.035 |
| Salmeterol | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 | 3.495 L | Standard Error 0.033 |
| Placebo | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 | 3.307 L | Standard Error 0.034 |
Secondary
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
Time frame: After 16 weeks of treatment
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 | 3.488 L | Standard Error 0.034 |
| Salmeterol | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 | 3.474 L | Standard Error 0.033 |
| Placebo | Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 | 3.353 L | Standard Error 0.034 |
Secondary
Pulse Rate in Conjunction With Spirometry at Visit 3
Pulse rate collected in conjunction with spirometry at 6 weeks
Time frame: After 6 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Pulse Rate in Conjunction With Spirometry at Visit 3 | 74.7 bpm | Standard Deviation 8.8 |
| Salmeterol | Pulse Rate in Conjunction With Spirometry at Visit 3 | 74.9 bpm | Standard Deviation 8.4 |
| Placebo | Pulse Rate in Conjunction With Spirometry at Visit 3 | 74.2 bpm | Standard Deviation 9.4 |
Secondary
Pulse Rate in Conjunction With Spirometry at Visit 4
Pulse rate collected in conjunction with spirometry at 12 weeks
Time frame: After 12 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Pulse Rate in Conjunction With Spirometry at Visit 4 | 74.8 bpm | Standard Deviation 9.9 |
| Salmeterol | Pulse Rate in Conjunction With Spirometry at Visit 4 | 74.6 bpm | Standard Deviation 9.2 |
| Placebo | Pulse Rate in Conjunction With Spirometry at Visit 4 | 74.2 bpm | Standard Deviation 8.4 |
Secondary
Pulse Rate in Conjunction With Spirometry at Visit 5
Pulse rate collected in conjunction with spirometry at 16 weeks
Time frame: After 16 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Pulse Rate in Conjunction With Spirometry at Visit 5 | 74.4 bpm | Standard Deviation 9.9 |
| Salmeterol | Pulse Rate in Conjunction With Spirometry at Visit 5 | 75.3 bpm | Standard Deviation 8.3 |
| Placebo | Pulse Rate in Conjunction With Spirometry at Visit 5 | 74.7 bpm | Standard Deviation 10.1 |
Secondary
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
Systolic blood pressure collected in conjunction with spirometry at 6 weeks
Time frame: After 6 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 124.68 mmHg | Standard Deviation 14.53 |
| Salmeterol | Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 123.11 mmHg | Standard Deviation 11.5 |
| Placebo | Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 | 126.41 mmHg | Standard Deviation 14.48 |
Secondary
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
Systolic blood pressure collected in conjunction with spirometry at 12 weeks
Time frame: After 12 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 124.81 mmHg | Standard Deviation 13.86 |
| Salmeterol | Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 123.92 mmHg | Standard Deviation 12.15 |
| Placebo | Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 | 125.18 mmHg | Standard Deviation 13.45 |
Secondary
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
Systolic blood pressure collected in conjunction with spirometry at 16 weeks
Time frame: After 16 weeks of treatment
Population: Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium | Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 124.23 mmHg | Standard Deviation 14.59 |
| Salmeterol | Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 123.83 mmHg | Standard Deviation 12.82 |
| Placebo | Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 | 124.47 mmHg | Standard Deviation 13.77 |