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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

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ClinicalTrials.gov Identifier: NCT00350207
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : November 17, 2009
Last Update Posted : December 24, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Tiotropium bromide
Drug: Placebo
Drug: Salmeterol xinafoate
Enrollment 388
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description Tiotropium inhalation solution, 5mcg once daily PM Salmeterol Metered Aerosol, 50mcg twice daily Matching Placebo
Period Title: Overall Study
Started 128 134 126
Completed 120 128 119
Not Completed 8 6 7
Reason Not Completed
Adverse Event             5             2             2
Lack of Efficacy             1             0             2
Lost to Follow-up             1             0             1
Withdrawal by Subject             0             1             1
Other             1             3             1
Arm/Group Title Tiotropium Salmeterol Placebo Total
Hide Arm/Group Description Tiotropium inhalation solution, 5mcg once daily PM Salmeterol Metered Aerosol, 50mcg twice daily Matching Placebo Total of all reporting groups
Overall Number of Baseline Participants 128 134 126 388
Hide Baseline Analysis Population Description
Treated set includes all patients who were dispensed randomised study medication and were documented to have taken at least one dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 134 participants 126 participants 388 participants
43.5  (12.6) 42.3  (13.4) 44.0  (11.9) 43.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 134 participants 126 participants 388 participants
Female
82
  64.1%
83
  61.9%
75
  59.5%
240
  61.9%
Male
46
  35.9%
51
  38.1%
51
  40.5%
148
  38.1%
1.Primary Outcome
Title Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
-3.93  (4.873) -3.15  (4.64) -24.63  (4.835)
2.Secondary Outcome
Title Mean Weekly Morning Peak Expiratory Flow at Week 4
Hide Description Mean weekly morning peak expiratory flow at week 4, pre-dose
Time Frame After 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
360.695  (4.244) 359.762  (4.041) 335.515  (4.211)
3.Secondary Outcome
Title Mean Weekly Morning Peak Expiratory Flow at Week 8
Hide Description Mean weekly morning peak expiratory flow at week 8, pre-dose
Time Frame After 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
355.42  (4.646) 350.53  (4.424) 330.193  (4.61)
4.Secondary Outcome
Title Mean Weekly Morning Peak Expiratory Flow at Week 12
Hide Description Mean weekly morning peak expiratory flow at week 12, pre-dose
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
359.05  (4.885) 351.3  (4.652) 332.808  (4.847)
5.Secondary Outcome
Title Mean Weekly Morning Peak Expiratory Flow at Week 16
Hide Description Mean weekly morning peak expiratory flow at week 16, pre-dose
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
355.619  (4.868) 355.799  (4.636) 334.525  (4.831)
6.Secondary Outcome
Title Mean Weekly Evening Peak Expiratory Flow at Week 4
Hide Description Mean weekly evening peak expiratory flow at week 4, pre-dose
Time Frame After 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
374.496  (4.249) 366.219  (4.045) 348.344  (4.213)
7.Secondary Outcome
Title Mean Weekly Evening Peak Expiratory Flow at Week 8
Hide Description Mean weekly evening peak expiratory flow at week 8, pre-dose
Time Frame After 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
368.758  (4.78) 359.586  (4.551) 345.299  (4.74)
8.Secondary Outcome
Title Mean Weekly Evening Peak Expiratory Flow at Week 12
Hide Description Mean weekly evening peak expiratory flow at week 12, pre-dose
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
366.282  (4.851) 362.01  (4.617) 344.291  (4.81)
9.Secondary Outcome
Title Mean Weekly Evening Peak Expiratory Flow at Week 16
Hide Description Mean weekly evening peak expiratory flow at week 16, pre-dose
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L/min
363.657  (5.242) 360.304  (4.99) 340.099  (5.198)
10.Secondary Outcome
Title Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
Hide Description Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
Time Frame After 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.301  (0.026) 2.316  (0.024) 2.161  (0.025)
11.Secondary Outcome
Title Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
Hide Description Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
Time Frame After 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.254  (0.028) 2.287  (0.027) 2.164  (0.028)
12.Secondary Outcome
Title Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
Hide Description Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.256  (0.03) 2.254  (0.029) 2.156  (0.03)
13.Secondary Outcome
Title Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
Hide Description Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.3  (0.03) 2.278  (0.028) 2.188  (0.029)
14.Secondary Outcome
Title Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
Hide Description Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
Time Frame After 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.369  (0.029) 2.318  (0.028) 2.25  (0.029)
15.Secondary Outcome
Title Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
Hide Description Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
Time Frame After 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.32  (0.03) 2.301  (0.029) 2.239  (0.03)
16.Secondary Outcome
Title Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
Hide Description Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.31  (0.032) 2.299  (0.03) 2.231  (0.032)
17.Secondary Outcome
Title Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
Hide Description Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.343  (0.031) 2.291  (0.029) 2.215  (0.031)
18.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.267  (0.029) 1.22  (0.027) 1.232  (0.029)
19.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.182  (0.027) 1.176  (0.025) 1.21  (0.027)
20.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.203  (0.031) 1.194  (0.03) 1.224  (0.032)
21.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.196  (0.034) 1.135  (0.033) 1.185  (0.034)
22.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.612  (0.041) 1.486  (0.038) 1.615  (0.041)
23.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.504  (0.043) 1.481  (0.041) 1.613  (0.043)
24.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.519  (0.046) 1.436  (0.045) 1.542  (0.047)
25.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.536  (0.052) 1.461  (0.051) 1.647  (0.052)
26.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.735  (0.045) 1.637  (0.043) 1.744  (0.045)
27.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.603  (0.046) 1.569  (0.043) 1.699  (0.046)
28.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.572  (0.05) 1.495  (0.049) 1.682  (0.051)
29.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.609  (0.054) 1.476  (0.053) 1.711  (0.054)
30.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.549  (0.041) 1.514  (0.039) 1.583  (0.041)
31.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.475  (0.041) 1.478  (0.039) 1.545  (0.042)
32.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.458  (0.045) 1.436  (0.044) 1.52  (0.046)
33.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.446  (0.049) 1.415  (0.047) 1.593  (0.049)
34.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.699  (0.045) 1.627  (0.043) 1.735  (0.045)
35.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.557  (0.047) 1.571  (0.045) 1.643  (0.048)
36.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.57  (0.048) 1.482  (0.047) 1.62  (0.049)
37.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.623  (0.057) 1.482  (0.055) 1.691  (0.057)
38.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.679  (0.048) 1.605  (0.046) 1.652  (0.049)
39.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.519  (0.05) 1.56  (0.047) 1.575  (0.05)
40.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.539  (0.051) 1.505  (0.05) 1.572  (0.052)
41.Secondary Outcome
Title Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
1.528  (0.057) 1.515  (0.056) 1.669  (0.057)
42.Secondary Outcome
Title Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.471  (0.031) 2.401  (0.03) 2.299  (0.031)
43.Secondary Outcome
Title Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.467  (0.031) 2.442  (0.03) 2.266  (0.031)
44.Secondary Outcome
Title Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
2.439  (0.03) 2.457  (0.029) 2.29  (0.03)
45.Secondary Outcome
Title Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
Hide Description Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
Time Frame After 6 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
3.531  (0.034) 3.441  (0.033) 3.367  (0.034)
46.Secondary Outcome
Title Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
Hide Description Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
3.509  (0.035) 3.495  (0.033) 3.307  (0.034)
47.Secondary Outcome
Title Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
Hide Description Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: L
3.488  (0.034) 3.474  (0.033) 3.353  (0.034)
48.Secondary Outcome
Title Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
5.050  (0.067) 5.259  (0.064) 5.097  (0.067)
49.Secondary Outcome
Title Mini-AQLQ Overall Score at Visit 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
5.233  (0.066) 5.399  (0.063) 5.078  (0.066)
50.Secondary Outcome
Title Mini-AQLQ Overall Score at Visit 5
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: Unit on a scale
5.305  (0.068) 5.454  (0.064) 5.214  (0.067)
51.Secondary Outcome
Title Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
Hide Description Systolic blood pressure collected in conjunction with spirometry at 6 weeks
Time Frame After 6 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 126 131 122
Mean (Standard Deviation)
Unit of Measure: mmHg
124.68  (14.53) 123.11  (11.5) 126.41  (14.48)
52.Secondary Outcome
Title Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
Hide Description Systolic blood pressure collected in conjunction with spirometry at 12 weeks
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 121 129 119
Mean (Standard Deviation)
Unit of Measure: mmHg
124.81  (13.86) 123.92  (12.15) 125.18  (13.45)
53.Secondary Outcome
Title Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
Hide Description Systolic blood pressure collected in conjunction with spirometry at 16 weeks
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 122 128 119
Mean (Standard Deviation)
Unit of Measure: mmHg
124.23  (14.59) 123.83  (12.82) 124.47  (13.77)
54.Secondary Outcome
Title Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
Hide Description Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
Time Frame After 6 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 126 131 122
Mean (Standard Deviation)
Unit of Measure: mmHg
78.62  (9.26) 77.62  (8.74) 79.34  (8.37)
55.Secondary Outcome
Title Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
Hide Description Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 121 129 119
Mean (Standard Deviation)
Unit of Measure: mmHg
77.88  (9.93) 77.22  (9.23) 78.29  (8.04)
56.Secondary Outcome
Title Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
Hide Description Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 122 128 119
Mean (Standard Deviation)
Unit of Measure: mmHg
79.23  (9.35) 77.61  (7.92) 78.38  (9.38)
57.Secondary Outcome
Title Pulse Rate in Conjunction With Spirometry at Visit 3
Hide Description Pulse rate collected in conjunction with spirometry at 6 weeks
Time Frame After 6 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 125 131 121
Mean (Standard Deviation)
Unit of Measure: bpm
74.7  (8.8) 74.9  (8.4) 74.2  (9.4)
58.Secondary Outcome
Title Pulse Rate in Conjunction With Spirometry at Visit 4
Hide Description Pulse rate collected in conjunction with spirometry at 12 weeks
Time Frame After 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 121 129 119
Mean (Standard Deviation)
Unit of Measure: bpm
74.8  (9.9) 74.6  (9.2) 74.2  (8.4)
59.Secondary Outcome
Title Pulse Rate in Conjunction With Spirometry at Visit 5
Hide Description Pulse rate collected in conjunction with spirometry at 16 weeks
Time Frame After 16 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 121 128 119
Mean (Standard Deviation)
Unit of Measure: bpm
74.4  (9.9) 75.3  (8.3) 74.7  (10.1)
60.Secondary Outcome
Title Mean PEF Variability at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: ratio expressed in percent
12.043  (0.611) 10.547  (0.584) 12.085  (0.606)
61.Secondary Outcome
Title Mean PEF Variability at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: ratio expressed in percent
13.377  (0.695) 11.252  (0.664) 12.964  (0.689)
62.Secondary Outcome
Title Mean PEF Variability at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: ratio expressed in percent
11.735  (0.654) 11.320  (0.625) 11.257  (0.648)
63.Secondary Outcome
Title Mean PEF Variability at Week 16
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description:
Tiotropium inhalation solution, 5mcg once daily PM
Salmeterol Metered Aerosol, 50mcg twice daily
Matching Placebo
Overall Number of Participants Analyzed 128 134 125
Least Squares Mean (Standard Error)
Unit of Measure: ratio expressed in percent
11.742  (0.656) 10.793  (0.627) 12.305  (0.650)
Time Frame From first study drug administration until 30 days after last randomised study drug administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tiotropium Salmeterol Placebo
Hide Arm/Group Description Tiotropium inhalation solution, 5mcg once daily PM Salmeterol Metered Aerosol, 50mcg twice daily Matching Placebo
All-Cause Mortality
Tiotropium Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tiotropium Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/128 (1.56%)   7/134 (5.22%)   1/126 (0.79%) 
Gastrointestinal disorders       
Abdominal pain upper  1  0/128 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Nausea  1  0/128 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Infections and infestations       
Gastroenteritis  1  0/128 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Meningitis  1  1/128 (0.78%)  0/134 (0.00%)  0/126 (0.00%) 
Pilonidal cyst  1  1/128 (0.78%)  0/134 (0.00%)  0/126 (0.00%) 
Injury, poisoning and procedural complications       
Joint injury  1  0/128 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Ligament injury  1  0/128 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Nervous system disorders       
Headache  1  0/128 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/128 (0.00%)  4/134 (2.99%)  1/126 (0.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tiotropium Salmeterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/128 (16.41%)   18/134 (13.43%)   25/126 (19.84%) 
Infections and infestations       
Nasopharyngitis  1  5/128 (3.91%)  3/134 (2.24%)  9/126 (7.14%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  16/128 (12.50%)  15/134 (11.19%)  16/126 (12.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00350207     History of Changes
Other Study ID Numbers: 205.342
First Submitted: July 7, 2006
First Posted: July 10, 2006
Results First Submitted: August 24, 2009
Results First Posted: November 17, 2009
Last Update Posted: December 24, 2013