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CompletedNCT00350207Updated Dec 24, 2013Results posted

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

A Phase 2 interventional study of Tiotropium bromide and Placebo in Asthma, sponsored by Boehringer Ingelheim. Completed at 109 sites in 14 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-24.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
388
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

Browse trials for

03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 388 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
388 participants (actual)

Interventions

  • DrugTiotropium bromide
  • DrugPlacebo
  • DrugSalmeterol xinafoate
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

07

Results

Posted Nov 17, 2009

Participant flow

Participant flow — Overall Study
MilestoneTiotropiumSalmeterolPlacebo
Started128134126
Completed120128119
Not completed867
Withdrew: Adverse event522
Withdrew: Lack of efficacy102
Withdrew: Lost to follow-up101
Withdrew: Withdrawal by subject011
Withdrew: Other131

Outcome measures

PrimaryChange 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
Reported as:
Least squares mean · L/min
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
L/minTiotropiumSalmeterolPlacebo
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial-3.93 ± 4.873-3.15 ± 4.64-24.63 ± 4.835
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Morning Peak Expiratory Flow at Week 4
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Morning Peak Expiratory Flow at Week 4360.695 ± 4.244359.762 ± 4.041335.515 ± 4.211
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Morning Peak Expiratory Flow at Week 8
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Morning Peak Expiratory Flow at Week 8355.42 ± 4.646350.53 ± 4.424330.193 ± 4.61
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Morning Peak Expiratory Flow at Week 12
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Morning Peak Expiratory Flow at Week 12359.05 ± 4.885351.3 ± 4.652332.808 ± 4.847
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Morning Peak Expiratory Flow at Week 16
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Morning Peak Expiratory Flow at Week 16355.619 ± 4.868355.799 ± 4.636334.525 ± 4.831
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Evening Peak Expiratory Flow at Week 4
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Evening Peak Expiratory Flow at Week 4374.496 ± 4.249366.219 ± 4.045348.344 ± 4.213
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Evening Peak Expiratory Flow at Week 8
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Evening Peak Expiratory Flow at Week 8368.758 ± 4.78359.586 ± 4.551345.299 ± 4.74
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Evening Peak Expiratory Flow at Week 12
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Evening Peak Expiratory Flow at Week 12366.282 ± 4.851362.01 ± 4.617344.291 ± 4.81
SecondaryMean 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
Reported as:
Least squares mean · L/min
Mean Weekly Evening Peak Expiratory Flow at Week 16
L/minTiotropiumSalmeterolPlacebo
Mean Weekly Evening Peak Expiratory Flow at Week 16363.657 ± 5.242360.304 ± 4.99340.099 ± 5.198
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
LTiotropiumSalmeterolPlacebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 42.301 ± 0.0262.316 ± 0.0242.161 ± 0.025
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
LTiotropiumSalmeterolPlacebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 82.254 ± 0.0282.287 ± 0.0272.164 ± 0.028
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
LTiotropiumSalmeterolPlacebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 122.256 ± 0.032.254 ± 0.0292.156 ± 0.03
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
LTiotropiumSalmeterolPlacebo
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 162.3 ± 0.032.278 ± 0.0282.188 ± 0.029
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
LTiotropiumSalmeterolPlacebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 42.369 ± 0.0292.318 ± 0.0282.25 ± 0.029
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
LTiotropiumSalmeterolPlacebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 82.32 ± 0.032.301 ± 0.0292.239 ± 0.03
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
LTiotropiumSalmeterolPlacebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 122.31 ± 0.0322.299 ± 0.032.231 ± 0.032
SecondaryMean 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
Reported as:
Least squares mean · L
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
LTiotropiumSalmeterolPlacebo
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 162.343 ± 0.0312.291 ± 0.0292.215 ± 0.031
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 41.267 ± 0.0291.22 ± 0.0271.232 ± 0.029
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 81.182 ± 0.0271.176 ± 0.0251.21 ± 0.027
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 121.203 ± 0.0311.194 ± 0.031.224 ± 0.032
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 161.196 ± 0.0341.135 ± 0.0331.185 ± 0.034
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 41.612 ± 0.0411.486 ± 0.0381.615 ± 0.041
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 81.504 ± 0.0431.481 ± 0.0411.613 ± 0.043
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 121.519 ± 0.0461.436 ± 0.0451.542 ± 0.047
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 161.536 ± 0.0521.461 ± 0.0511.647 ± 0.052
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 41.735 ± 0.0451.637 ± 0.0431.744 ± 0.045
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 81.603 ± 0.0461.569 ± 0.0431.699 ± 0.046
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 121.572 ± 0.051.495 ± 0.0491.682 ± 0.051
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 161.609 ± 0.0541.476 ± 0.0531.711 ± 0.054
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 41.549 ± 0.0411.514 ± 0.0391.583 ± 0.041
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 81.475 ± 0.0411.478 ± 0.0391.545 ± 0.042
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 121.458 ± 0.0451.436 ± 0.0441.52 ± 0.046
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 161.446 ± 0.0491.415 ± 0.0471.593 ± 0.049
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 41.699 ± 0.0451.627 ± 0.0431.735 ± 0.045
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 81.557 ± 0.0471.571 ± 0.0451.643 ± 0.048
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 121.57 ± 0.0481.482 ± 0.0471.62 ± 0.049
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
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 scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 161.623 ± 0.0571.482 ± 0.0551.691 ± 0.057
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 41.679 ± 0.0481.605 ± 0.0461.652 ± 0.049
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 81.519 ± 0.051.56 ± 0.0471.575 ± 0.05
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 121.539 ± 0.0511.505 ± 0.051.572 ± 0.052
SecondaryMean 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
Reported as:
Least squares mean · Unit on a scale
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16
Unit on a scaleTiotropiumSalmeterolPlacebo
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 161.528 ± 0.0571.515 ± 0.0561.669 ± 0.057
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 32.471 ± 0.0312.401 ± 0.032.299 ± 0.031
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 42.467 ± 0.0312.442 ± 0.032.266 ± 0.031
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 52.439 ± 0.032.457 ± 0.0292.29 ± 0.03
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 33.531 ± 0.0343.441 ± 0.0333.367 ± 0.034
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 43.509 ± 0.0353.495 ± 0.0333.307 ± 0.034
SecondaryMorning 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
Reported as:
Least squares mean · L
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
LTiotropiumSalmeterolPlacebo
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 53.488 ± 0.0343.474 ± 0.0333.353 ± 0.034
SecondaryMini-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
Reported as:
Least squares mean · Unit on a scale
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
Unit on a scaleTiotropiumSalmeterolPlacebo
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 35.050 ± 0.0675.259 ± 0.0645.097 ± 0.067
SecondaryMini-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
Reported as:
Least squares mean · Unit on a scale
Mini-AQLQ Overall Score at Visit 4
Unit on a scaleTiotropiumSalmeterolPlacebo
Mini-AQLQ Overall Score at Visit 45.233 ± 0.0665.399 ± 0.0635.078 ± 0.066
SecondaryMini-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
Reported as:
Least squares mean · Unit on a scale
Mini-AQLQ Overall Score at Visit 5
Unit on a scaleTiotropiumSalmeterolPlacebo
Mini-AQLQ Overall Score at Visit 55.305 ± 0.0685.454 ± 0.0645.214 ± 0.067
SecondarySystolic 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
Reported as:
Mean · mmHg
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
mmHgTiotropiumSalmeterolPlacebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3124.68 ± 14.53123.11 ± 11.5126.41 ± 14.48
SecondarySystolic 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
Reported as:
Mean · mmHg
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
mmHgTiotropiumSalmeterolPlacebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4124.81 ± 13.86123.92 ± 12.15125.18 ± 13.45
SecondarySystolic 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
Reported as:
Mean · mmHg
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
mmHgTiotropiumSalmeterolPlacebo
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5124.23 ± 14.59123.83 ± 12.82124.47 ± 13.77
SecondaryDiastolic 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
Reported as:
Mean · mmHg
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
mmHgTiotropiumSalmeterolPlacebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 378.62 ± 9.2677.62 ± 8.7479.34 ± 8.37
SecondaryDiastolic 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
Reported as:
Mean · mmHg
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
mmHgTiotropiumSalmeterolPlacebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 477.88 ± 9.9377.22 ± 9.2378.29 ± 8.04
SecondaryDiastolic 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
Reported as:
Mean · mmHg
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
mmHgTiotropiumSalmeterolPlacebo
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 579.23 ± 9.3577.61 ± 7.9278.38 ± 9.38
SecondaryPulse 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
Reported as:
Mean · bpm
Pulse Rate in Conjunction With Spirometry at Visit 3
bpmTiotropiumSalmeterolPlacebo
Pulse Rate in Conjunction With Spirometry at Visit 374.7 ± 8.874.9 ± 8.474.2 ± 9.4
SecondaryPulse 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
Reported as:
Mean · bpm
Pulse Rate in Conjunction With Spirometry at Visit 4
bpmTiotropiumSalmeterolPlacebo
Pulse Rate in Conjunction With Spirometry at Visit 474.8 ± 9.974.6 ± 9.274.2 ± 8.4
SecondaryPulse 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
Reported as:
Mean · bpm
Pulse Rate in Conjunction With Spirometry at Visit 5
bpmTiotropiumSalmeterolPlacebo
Pulse Rate in Conjunction With Spirometry at Visit 574.4 ± 9.975.3 ± 8.374.7 ± 10.1
SecondaryMean 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
Reported as:
Least squares mean · ratio expressed in percent
Mean PEF Variability at Week 4
ratio expressed in percentTiotropiumSalmeterolPlacebo
Mean PEF Variability at Week 412.043 ± 0.61110.547 ± 0.58412.085 ± 0.606
SecondaryMean 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
Reported as:
Least squares mean · ratio expressed in percent
Mean PEF Variability at Week 8
ratio expressed in percentTiotropiumSalmeterolPlacebo
Mean PEF Variability at Week 813.377 ± 0.69511.252 ± 0.66412.964 ± 0.689
SecondaryMean 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
Reported as:
Least squares mean · ratio expressed in percent
Mean PEF Variability at Week 12
ratio expressed in percentTiotropiumSalmeterolPlacebo
Mean PEF Variability at Week 1211.735 ± 0.65411.320 ± 0.62511.257 ± 0.648
SecondaryMean 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
Reported as:
Least squares mean · ratio expressed in percent
Mean PEF Variability at Week 16
ratio expressed in percentTiotropiumSalmeterolPlacebo
Mean PEF Variability at Week 1611.742 ± 0.65610.793 ± 0.62712.305 ± 0.650

Adverse events

Collected over From first study drug administration until 30 days after last randomised study drug administration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tiotropium—2/128 (1.6%)21/128 (16.4%)
Salmeterol—7/134 (5.2%)18/134 (13.4%)
Placebo—1/126 (0.8%)25/126 (19.8%)
Most frequent serious events
Most frequent serious events
EventTiotropiumSalmeterolPlacebo
AsthmaRespiratory, thoracic and mediastinal disorders0/1284/1341/126
Abdominal pain upperGastrointestinal disorders0/1280/1341/126
MeningitisInfections and infestations1/1280/1340/126
Pilonidal cystInfections and infestations1/1280/1340/126
NauseaGastrointestinal disorders0/1281/1340/126
GastroenteritisInfections and infestations0/1281/1340/126
Joint injuryInjury, poisoning and procedural complications0/1281/1340/126
Ligament injuryInjury, poisoning and procedural complications0/1281/1340/126
HeadacheNervous system disorders0/1281/1340/126
Most frequent other events
Most frequent other events
EventTiotropiumSalmeterolPlacebo
AsthmaRespiratory, thoracic and mediastinal disorders16/12815/13416/126
NasopharyngitisInfections and infestations5/1283/1349/126

Baseline characteristics

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
Age, Continuous(years)TiotropiumSalmeterolPlaceboTotal
Mean43.5 ± 12.642.3 ± 13.444.0 ± 11.943.3 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)TiotropiumSalmeterolPlaceboTotal
Female828375240
Male465151148
08

Study locations

109 sites
  • 205.342.43002 Boehringer Ingelheim Investigational Site
    Graz, Austria
  • 205.342.43004 Boehringer Ingelheim Investigational Site
    Trofaiach, Austria
  • 205.342.43003 Boehringer Ingelheim Investigational Site
    Wels, Austria
  • 205.342.43001 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 205.342.43005 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 205.342.43006 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 205.342.43007 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 205.342.32010 Boehringer Ingelheim Investigational Site
    Anderlecht, Belgium
  • 205.342.32005 Boehringer Ingelheim Investigational Site
    Angleur, Belgium
  • 205.342.32002 Boehringer Ingelheim Investigational Site
    Brussel, Belgium
  • 205.342.32007 Boehringer Ingelheim Investigational Site
    Bruxelles, Belgium
  • 205.342.32014 Boehringer Ingelheim Investigational Site
    Bruxelles, Belgium
  • 205.342.32001 Boehringer Ingelheim Investigational Site
    Gent, Belgium
  • 205.342.32003 Boehringer Ingelheim Investigational Site
    Herentals, Belgium
  • 205.342.32004 Boehringer Ingelheim Investigational Site
    Malmédy, Belgium
  • 205.342.32012 Boehringer Ingelheim Investigational Site
    Menen, Belgium
  • 205.342.32006 Boehringer Ingelheim Investigational Site
    Montigny-le-Tilleul, Belgium
  • 205.342.32009 Boehringer Ingelheim Investigational Site
    Namur, Belgium
  • 205.342.32011 Boehringer Ingelheim Investigational Site
    Turnhout, Belgium
  • 205.342.32013 Boehringer Ingelheim Investigational Site
    Yvoir, Belgium
  • 205.342.45003 Boehringer Ingelheim Investigational Site
    Aalborg, Denmark
  • 205.342.45001 Boehringer Ingelheim Investigational Site
    Hvidovre, Denmark
  • 205.342.45002 Boehringer Ingelheim Investigational Site
    Kobenhavn NV, Denmark
  • 205.342.45004 Boehringer Ingelheim Investigational Site
    Odense C, Denmark
  • 205.342.35803 Boehringer Ingelheim Investigational Site
    Helsinki, Finland
  • 205.342.35801 Boehringer Ingelheim Investigational Site
    Jyväskylä, Finland
  • 205.342.35802 Boehringer Ingelheim Investigational Site
    Lahti, Finland
  • 205.342.35804 Boehringer Ingelheim Investigational Site
    Tampere, Finland
  • 205.342.3305A Centre Hosp de la Cavale Blanche
    Brest, France
  • 205.342.3304A Cabinet Médical
    Chamalières, France
  • 205.342.3307A Boehringer Ingelheim Investigational Site
    Chauny, France
  • 205.342.3301A UCP-X - Clinique Médicale
    Grenoble, France
  • 205.342.3302A Hôpital Arnaud de Villeneuve
    Montpellier, France
  • 205.342.3306A Mediscis
    Poitiers, France
  • 205.342.3308A Boehringer Ingelheim Investigational Site
    Saint Pierre la Réunion, France
  • 205.342.3308B Boehringer Ingelheim Investigational Site
    Saint Pierre la Réunion, France
  • 205.342.49016 Boehringer Ingelheim Investigational Site
    Beelitz-Heilstätten, Germany
  • 205.342.49004 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 205.342.49006 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 205.342.49013 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 205.342.49003 Boehringer Ingelheim Investigational Site
    Bruchsal, Germany
  • 205.342.49011 Boehringer Ingelheim Investigational Site
    Frankfurt/Main, Germany
  • 205.342.49007 Boehringer Ingelheim Investigational Site
    Kassel, Germany
  • 205.342.49009 Boehringer Ingelheim Investigational Site
    Köln, Germany
  • 205.342.49010 Boehringer Ingelheim Investigational Site
    Mainz, Germany
  • 205.342.49008 Boehringer Ingelheim Investigational Site
    Minden, Germany
  • 205.342.49015 Boehringer Ingelheim Investigational Site
    Neuruppin, Germany
  • 205.342.49012 Boehringer Ingelheim Investigational Site
    Rathenow, Germany
  • 205.342.49005 Boehringer Ingelheim Investigational Site
    Rüdersdorf, Germany
  • 205.342.49002 Boehringer Ingelheim Investigational Site
    Weinheim, Germany
  • 205.342.30001 Boehringer Ingelheim Investigational Site
    Athens, Greece
  • 205.342.30002 Boehringer Ingelheim Investigational Site
    Athens, Greece
  • 205.342.30005 Boehringer Ingelheim Investigational Site
    Heraklion, Greece
  • 205.342.30006 Boehringer Ingelheim Investigational Site
    Kavala, Greece
  • 205.342.30004 Boehringer Ingelheim Investigational Site
    Larisa, Greece
  • 205.342.30003 Boehringer Ingelheim Investigational Site
    Thessaloniki, Greece
  • 205.342.39003 Azienda Ospedaliera " S. Anna"
    Ferrara, Italy
  • 205.342.39006 Azienda Ospedaliera Universitaria Careggi
    Firenze, Italy
  • 205.342.39005 Ospedale San Martino
    Genova, Italy
  • 205.342.39002 Università di Modena e Reggio Emilia
    Modena, Italy
  • 205.342.39010 Boehringer Ingelheim Investigational Site
    Orbassano (to), Italy
  • 205.342.39007 Policlinico San Matteo
    Pavia, Italy
  • 205.342.39001 Ospedale di Cisanello
    Pisa, Italy
  • 205.342.39009 Boehringer Ingelheim Investigational Site
    Sesto San Giovanni (mi), Italy
  • 205.342.07001 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 205.342.07002 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 205.342.07003 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 205.342.07004 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 205.342.07005 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 205.342.07006 Boehringer Ingelheim Investigational Site
    St. Petersburg, Russian Federation
  • 205.342.07007 Boehringer Ingelheim Investigational Site
    St. Petersburg, Russian Federation
  • 205.342.07008 Boehringer Ingelheim Investigational Site
    St. Petersburg, Russian Federation
  • 205.342.42101 Boehringer Ingelheim Investigational Site
    Banska Bystrica, Slovakia
  • 205.342.42102 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 205.342.42104 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 205.342.42105 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 205.342.42107 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 205.342.42103 Boehringer Ingelheim Investigational Site
    Kosice, Slovakia
  • 205.342.42106 Boehringer Ingelheim Investigational Site
    Trencin, Slovakia
  • 205.342.42108 Boehringer Ingelheim Investigational Site
    Zilina, Slovakia
  • 205.342.27002 Boehringer Ingelheim Investigational Site
    Bellville, South Africa
  • 205.342.27008 Boehringer Ingelheim Investigational Site
    Bloemfontein, South Africa
  • 205.342.27001 Boehringer Ingelheim Investigational Site
    Cape Town, South Africa
  • 205.342.27004 Boehringer Ingelheim Investigational Site
    Cape Town, South Africa
  • 205.342.27006 Boehringer Ingelheim Investigational Site
    Centurion, South Africa
  • 205.342.27003 Boehringer Ingelheim Investigational Site
    Durban, South Africa
  • 205.342.27007 Boehringer Ingelheim Investigational Site
    George, South Africa
  • 205.342.27005 Boehringer Ingelheim Investigational Site
    Pretoria, South Africa
  • 205.342.34006 Hospital Clinic i Provincial de Barcelona
    Barcelona, Spain
  • 205.342.34011 Boehringer Ingelheim Investigational Site
    Centelles, Spain
  • 205.342.34004 Hospital General Universitario de Guadalajara
    Guadalajara, Spain
  • 205.342.34002 Hospital de Gran Canaria Dr. Negrín
    Las Palmas de Gran Canaria, Spain
  • 205.342.34007 Hospital Universitari Arnau de Vilanova
    Lleida, Spain
  • 205.342.34003 Hospital Universitario La Paz
    Madrid, Spain
  • 205.342.34009 Hospital Universio Puerta del Hierro
    Madrid, Spain
  • 205.342.34008 Hospital Universitario Marqués de Valdecilla
    Santander, Spain
  • 205.342.34005 Hospital Vírgen de la Macarena
    Sevilla, Spain
  • 205.342.34010 Hospital General Universitario de Valencia
    Valencia, Spain
  • 205.342.90001 Boehringer Ingelheim Investigational Site
    Ankara, Turkey
  • 205.342.90006 Boehringer Ingelheim Investigational Site
    Ankara, Turkey

Showing the first 100 of 109 sites across 14 countries.

09

References and documents

Publications

  • Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004. PubMed 21807250 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00350207
Lead sponsor
Boehringer Ingelheim
First posted
Jul 10, 2006
Start date
Jul 2006
Primary completion
Sep 2008
Results posted
Nov 17, 2009
Last update
Dec 24, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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