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CompletedNCT00168844Updated May 20, 2014Results posted

Tiotropium / Respimat One-Year Study

A Phase 3 interventional study of Tiotropium Inhalation Solution and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 73 sites in 14 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-05-20.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
983
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 983 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases 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
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
This record does not list eligibility criteria. Contact the study team before assuming you do or do not qualify.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
983 participants (actual)

Study arms

  • Other
    Tiotropium Respimat 5mcg (Tio R5)

    Drug: Tiotropium Inhalation Solution

  • Other
    Tiotropium Respimat 10mcg (Tio R10)

    Drug: Tiotropium Inhalation Solution

  • Other
    Placebo

    Other: Placebo

Interventions

  • DrugTiotropium Inhalation Solution
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)

    Trough Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

  2. Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)

    Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0

    Time frame: Week 48

  3. TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)

    Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.

    Time frame: Week 48

  4. COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)

    Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

    Time frame: 48 weeks

Secondary outcomes

  1. Change From Baseline in Heart Rate

    Week 40 pre-dose - baseline

    Time frame: Baseline to Week 40 pre-dose

  2. Change From Baseline in PR Interval

    Time frame: Baseline to Week 40 pre-dose

  3. Change From Baseline in QRS Interval

    Week 40 pre-dose - baseline

    Time frame: Baseline to Week 40 pre-dose

  4. Change From Baseline in QT Interval

    Week 40 pre-dose - baseline

    Time frame: Baseline to Week 40 pre-dose

  5. Change From Baseline in QT Interval (Bazett)

    Week 40 pre-dose - baseline

    Time frame: Baseline to Week 40 pre-dose

  6. Change From Baseline in QT Interval (Fridericia)

    Week 40 pre-dose - baseline

    Time frame: Baseline to Week 40 pre-dose

  7. Change From Baseline in Heart Rate

    Week 40 - baseline

    Time frame: Baseline to Week 40

  8. Change From Baseline in Supraventricular Premature Beat (SVPB) Total

    Week 40 - baseline

    Time frame: Baseline to Week 40

  9. Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events

    Week 40 - baseline

    Time frame: Baseline to Week 40

  10. Change From Baseline in SVPB Pairs

    Week 40 - baseline

    Time frame: Baseline to Week 40

  11. Change From Baseline in Ventricular Premature Beat (VPB) Total

    Week 40 - baseline

    Time frame: Baseline to Week 40

  12. Change From Baseline in VPB Run Events

    Week 40 - baseline

    Time frame: Baseline to Week 40

  13. Change From Baseline in VPB Pairs

    Week 40 - baseline

    Time frame: Baseline to Week 40

  14. Change From Baseline in Haematocrit, Packed Cell Volume (PCV)

    Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  15. Change From Baseline in Haemoglobin

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  16. Change From Baseline in Red Blood Cell Count

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  17. Change From Baseline in White Blood Cell Count

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  18. Change From Baseline in Platelets

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  19. Change From Baseline in Neutrophils

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  20. Change From Baseline in Eosinophils

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  21. Change From Baseline in Basophils

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  22. Change From Baseline in Lymphocytes

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  23. Change From Baseline in Monocytes

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  24. Change From Baseline in Neutrophils (Absolute)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  25. Change From Baseline in Lymphocytes (Absolute)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  26. Change From Baseline in Eosinophils (Absolute)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  27. Change From Baseline in Basophils (Absolute)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  28. Change From Baseline in Monocytes (Absolute)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  29. Change From Baseline in Calcium

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  30. Change From Baseline in Phosphate

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  31. Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  32. Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  33. Change From Baseline in Alkaline Phosphatase

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  34. Change From Baseline in Lactic Dehydrogenase (LDH)

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  35. Change From Baseline in Glucose

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  36. Change From Baseline in Urea

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  37. Change From Baseline in Blood Urea Nitrogen

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  38. Change From Baseline in Creatinine

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  39. Change From Baseline in Bilirubin, Total

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  40. Change From Baseline in Uric Acid

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  41. Change From Baseline in Protein, Total

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  42. Change From Baseline in Albumin

    Week 48 - baseline

    Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48

  43. Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks

    Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

  44. Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks

    Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

  45. Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

    FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

  46. Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

    FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

  47. Weekly Mean Morning Pre-dose PEFRs

    Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48

  48. Weekly Mean Evening PEFRs

    Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48

  49. Weekly Mean Number of Puffs of Rescue Medication Per Day

    Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.

    Time frame: Weeks 2, 8, 16, 24, 32, 40, 48

  50. Mahler TDI Scores

    Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value. Worst score = -3, best score = +3

    Time frame: Week 48

  51. Saint George's Respiratory Questionnaire (SGRQ) Scores

    Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0. The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: Week 48

  52. COPD Symptoms Scores

    COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: Week 48

  53. PGE Scores

    Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1-2 = Poor, 3-4 = Fair, 5-6 = Good, 7-8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: Week 48

  54. PGR Score

    Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.

    Time frame: Week 48

07

Results

Posted Oct 7, 2009

Participant flow

Feb 2003 - Jun 2004, hospital and primary care clinics

Participant flow — Overall Study
MilestoneTiotropium Respimat 5mcg (Tio R5)Tiotropium Respimat 10mcg (Tio R10)Placebo
Started332332319
Completed277277228
Not completed555591
Withdrew: Adverse event313248
Withdrew: Lost to follow-up4511
Withdrew: Withdrawal by subject12919
Withdrew: Protocol violation224
Withdrew: Other679

Outcome measures

PrimaryChange From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)

Trough Forced Expiratory Volume in 1 second (FEV1)

Time frame:
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Reported as:
Mean · Litres
Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)
LitresTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)0.097 ± 0.0130.116 ± 0.014-0.046 ± 0.014
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.142Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.161Tiotropium Respimat 10mcg - Placebo
PrimarySaint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)

Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0

Time frame:
Week 48
Reported as:
Mean · Points on a scale
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)39.648 ± 0.67638.675 ± 0.67942.917 ± 0.728
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = 0.0011 · Mean difference (final values): -3.269Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): -4.242Tiotropium Respimat 10mcg - Placebo
PrimaryTDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)

Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.

Time frame:
Week 48
Reported as:
Mean · Points on a scale
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)1.890 ± 0.1121.913 ± 0.1130.837 ± 0.120
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 1.053Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 1.075The means are adjusted for centre, smoking status at entry and baseline value.
PrimaryCOPD Exacerbation Rate, Safety Set (SS) (Combined Studies)

Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

Time frame:
48 weeks
Reported as:
Mean · Number of exacerbations per patient year
COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
Number of exacerbations per patient yearTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)0.93 ± 2.021.02 ± 3.051.91 ± 8.17
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · Poisson regression · p = 0.0002 · Odds ratio (or): 0.782 · 95% CI 0.687 to 0.890Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · Poisson regression · p = <0.0001 · Odds ratio (or): 0.725 · 95% CI 0.635 to 0.828Tiotropium Respimat 10mcg - Placebo
SecondaryChange From Baseline in Heart Rate

Week 40 pre-dose - baseline

Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · beats per minute (bpm)
Change From Baseline in Heart Rate
beats per minute (bpm)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Heart Rate2.1 ± 12.43.6 ± 10.51.8 ± 9.7
SecondaryChange From Baseline in PR Interval
Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · milliseconds (msec)
Change From Baseline in PR Interval
milliseconds (msec)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in PR Interval-0.8 ± 20.2-2.5 ± 15.1-0.5 ± 15.3
SecondaryChange From Baseline in QRS Interval

Week 40 pre-dose - baseline

Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · msec
Change From Baseline in QRS Interval
msecTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in QRS Interval0.9 ± 9.41.7 ± 12.1-1.1 ± 10.3
SecondaryChange From Baseline in QT Interval

Week 40 pre-dose - baseline

Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · msec
Change From Baseline in QT Interval
msecTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in QT Interval-4.6 ± 26.5-3.5 ± 25.2-3.2 ± 22.3
SecondaryChange From Baseline in QT Interval (Bazett)

Week 40 pre-dose - baseline

Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · msec
Change From Baseline in QT Interval (Bazett)
msecTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in QT Interval (Bazett)-0.5 ± 29.95.4 ± 24.02.5 ± 23.4
SecondaryChange From Baseline in QT Interval (Fridericia)

Week 40 pre-dose - baseline

Time frame:
Baseline to Week 40 pre-dose
Reported as:
Mean · msec
Change From Baseline in QT Interval (Fridericia)
msecTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in QT Interval (Fridericia)-2.0 ± 24.32.2 ± 21.30.5 ± 19.5
SecondaryChange From Baseline in Heart Rate

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · bpm
Change From Baseline in Heart Rate
bpmTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Heart Rate0.3 ± 5.41.2 ± 6.40.3 ± 6.6
SecondaryChange From Baseline in Supraventricular Premature Beat (SVPB) Total

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · premature beats per 24 hours
Change From Baseline in Supraventricular Premature Beat (SVPB) Total
premature beats per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Supraventricular Premature Beat (SVPB) Total-3.4 ± 94.26.8 ± 87.420.9 ± 125.8
SecondaryHolter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · events per 24 hours
Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events
events per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events0.0 ± 0.6-0.1 ± 0.5-0.1 ± 1.6
SecondaryChange From Baseline in SVPB Pairs

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · pairs per 24 hours
Change From Baseline in SVPB Pairs
pairs per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in SVPB Pairs-0.4 ± 4.0-0.2 ± 2.32.0 ± 16.4
SecondaryChange From Baseline in Ventricular Premature Beat (VPB) Total

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · premature beats per 24 hours
Change From Baseline in Ventricular Premature Beat (VPB) Total
premature beats per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Ventricular Premature Beat (VPB) Total-14.3 ± 105.94.6 ± 68.8-24.1 ± 182.3
SecondaryChange From Baseline in VPB Run Events

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · events per 24 hours
Change From Baseline in VPB Run Events
events per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in VPB Run Events0.0 ± 0.10.0 ± 0.10.0 ± 0.0
SecondaryChange From Baseline in VPB Pairs

Week 40 - baseline

Time frame:
Baseline to Week 40
Reported as:
Mean · pairs per 24 hours
Change From Baseline in VPB Pairs
pairs per 24 hoursTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in VPB Pairs-0.2 ± 1.6-0.1 ± 3.8-0.9 ± 5.7
SecondaryChange From Baseline in Haematocrit, Packed Cell Volume (PCV)

Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · Percentage of erythrocytes
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Percentage of erythrocytesTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)0 ± 4-1 ± 40 ± 4
SecondaryChange From Baseline in Haemoglobin

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · grams per litre (g/L)
Change From Baseline in Haemoglobin
grams per litre (g/L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Haemoglobin-1 ± 10-2 ± 111 ± 12
SecondaryChange From Baseline in Red Blood Cell Count

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^12/Litre (L)
Change From Baseline in Red Blood Cell Count
10^12/Litre (L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Red Blood Cell Count0.0 ± 0.3-0.1 ± 0.30.0 ± 0.3
SecondaryChange From Baseline in White Blood Cell Count

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/Litre (L)
Change From Baseline in White Blood Cell Count
10^9/Litre (L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in White Blood Cell Count0.1 ± 1.40.0 ± 1.50.2 ± 1.5
SecondaryChange From Baseline in Platelets

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Platelets
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Platelets4 ± 301 ± 317 ± 30
SecondaryChange From Baseline in Neutrophils

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · percentage of white blood cell count
Change From Baseline in Neutrophils
percentage of white blood cell countTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Neutrophils1 ± 81 ± 81 ± 8
SecondaryChange From Baseline in Eosinophils

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · percentage of white blood cell count
Change From Baseline in Eosinophils
percentage of white blood cell countTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Eosinophils0 ± 20 ± 20 ± 2
SecondaryChange From Baseline in Basophils

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · percentage of white blood cell count
Change From Baseline in Basophils
percentage of white blood cell countTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Basophils0 ± 00 ± 00 ± 0
SecondaryChange From Baseline in Lymphocytes

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · percentage of white blood cell count
Change From Baseline in Lymphocytes
percentage of white blood cell countTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Lymphocytes-1 ± 4-1 ± 40 ± 4
SecondaryChange From Baseline in Monocytes

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · percentage of white blood cell count
Change From Baseline in Monocytes
percentage of white blood cell countTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Monocytes0 ± 40 ± 30 ± 4
SecondaryChange From Baseline in Neutrophils (Absolute)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Neutrophils (Absolute)
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Neutrophils (Absolute)0.2 ± 1.50.1 ± 1.60.2 ± 1.6
SecondaryChange From Baseline in Lymphocytes (Absolute)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Lymphocytes (Absolute)
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Lymphocytes (Absolute)0.0 ± 0.6-0.1 ± 0.70.1 ± 0.6
SecondaryChange From Baseline in Eosinophils (Absolute)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Eosinophils (Absolute)
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Eosinophils (Absolute)0.0 ± 0.10.0 ± 0.10.0 ± 0.1
SecondaryChange From Baseline in Basophils (Absolute)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Basophils (Absolute)
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Basophils (Absolute)0.0 ± 0.10.0 ± 0.10.0 ± 0.0
SecondaryChange From Baseline in Monocytes (Absolute)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · 10^9/L
Change From Baseline in Monocytes (Absolute)
10^9/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Monocytes (Absolute)0.0 ± 0.20.0 ± 0.20.0 ± 0.2
SecondaryChange From Baseline in Calcium

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · millimoles per litre (mmol/L)
Change From Baseline in Calcium
millimoles per litre (mmol/L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Calcium0.0 ± 0.10.0 ± 0.10.0 ± 0.2
SecondaryChange From Baseline in Phosphate

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · mmol/L
Change From Baseline in Phosphate
mmol/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Phosphate0.02 ± 0.250.00 ± 0.230.01 ± 0.23
SecondaryChange From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · Units per litre (U/L)
Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)
Units per litre (U/L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)-3 ± 17-1 ± 130 ± 17
SecondaryChange From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · U/L
Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)
U/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)-2 ± 13-1 ± 15-1 ± 15
SecondaryChange From Baseline in Alkaline Phosphatase

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · U/L
Change From Baseline in Alkaline Phosphatase
U/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Alkaline Phosphatase-3 ± 21-6 ± 20-5 ± 27
SecondaryChange From Baseline in Lactic Dehydrogenase (LDH)

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · U/L
Change From Baseline in Lactic Dehydrogenase (LDH)
U/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Lactic Dehydrogenase (LDH)4 ± 602 ± 870 ± 63
SecondaryChange From Baseline in Glucose

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · mmol/L
Change From Baseline in Glucose
mmol/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Glucose-0.09 ± 1.820.07 ± 1.950.17 ± 2.21
SecondaryChange From Baseline in Urea

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · mmol/L
Change From Baseline in Urea
mmol/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Urea0.1 ± 2.00.0 ± 2.30.0 ± 2.1
SecondaryChange From Baseline in Blood Urea Nitrogen

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · milligrams per decilitre (mg/dL)
Change From Baseline in Blood Urea Nitrogen
milligrams per decilitre (mg/dL)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Blood Urea Nitrogen0.1 ± 3.20.0 ± 3.7-0.1 ± 3.4
SecondaryChange From Baseline in Creatinine

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · micromoles per litre (umol/L)
Change From Baseline in Creatinine
micromoles per litre (umol/L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Creatinine2.7 ± 9.61.0 ± 11.11.7 ± 10.4
SecondaryChange From Baseline in Bilirubin, Total

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · umol/L
Change From Baseline in Bilirubin, Total
umol/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Bilirubin, Total0.0 ± 4.5-0.1 ± 4.40.0 ± 4.0
SecondaryChange From Baseline in Uric Acid

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · umol/L
Change From Baseline in Uric Acid
umol/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Uric Acid13.55 ± 78.131.03 ± 82.357.83 ± 88.05
SecondaryChange From Baseline in Protein, Total

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · grams per litre (g/L)
Change From Baseline in Protein, Total
grams per litre (g/L)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Protein, Total-1 ± 5-1 ± 5-1 ± 5
SecondaryChange From Baseline in Albumin

Week 48 - baseline

Time frame:
Baseline to Week 48 or at premature discontinuation if before Week 48
Reported as:
Mean · g/L
Change From Baseline in Albumin
g/LTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Change From Baseline in Albumin1 ± 41 ± 41 ± 4
SecondaryChange From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks

Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Reported as:
Mean · Litres
Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks
LitresTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 20.118 ± 0.0110.133 ± 0.0110.013 ± 0.012
Week 80.124 ± 0.0120.150 ± 0.012-0.004 ± 0.013
Week 160.121 ± 0.0130.125 ± 0.014-0.022 ± 0.014
Week 240.125 ± 0.0130.121 ± 0.013-0.009 ± 0.013
Week 320.124 ± 0.0130.132 ± 0.013-0.025 ± 0.014
Week 400.107 ± 0.0130.133 ± 0.013-0.031 ± 0.014
SecondaryChange From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks

Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Reported as:
Mean · Litres
Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks
LitresTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 20.163 ± 0.0230.278 ± 0.0240.025 ± 0.025
Week 80.168 ± 0.0240.300 ± 0.0240.009 ± 0.025
Week 160.145 ± 0.0260.267 ± 0.027-0.019 ± 0.028
Week 240.155 ± 0.0260.274 ± 0.026-0.012 ± 0.027
Week 320.156 ± 0.0260.276 ± 0.026-0.038 ± 0.028
Week 400.130 ± 0.0260.294 ± 0.027-0.043 ± 0.028
Week 480.108 ± 0.0270.253 ± 0.027-0.070 ± 0.028
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.178Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.323Tiotropium Respimat 10mcg - Placebo
SecondaryChange From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Reported as:
Mean · Litres
Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
LitresTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 20.256 ± 0.0120.258 ± 0.0120.045 ± 0.013
Week 80.246 ± 0.0130.274 ± 0.0130.041 ± 0.014
Week 160.241 ± 0.0140.248 ± 0.0140.024 ± 0.015
Week 240.242 ± 0.0140.241 ± 0.0140.026 ± 0.014
Week 320.239 ± 0.0140.240 ± 0.0140.019 ± 0.015
Week 400.225 ± 0.0140.233 ± 0.0140.003 ± 0.015
Week 480.212 ± 0.0140.226 ± 0.014-0.008 ± 0.015
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.220Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.234Tiotropium Respimat 10mcg - Placebo
SecondaryChange From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Reported as:
Mean · Litres
Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks
LitresTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 20.421 ± 0.0240.492 ± 0.0240.130 ± 0.025
Week 80.397 ± 0.0260.538 ± 0.0260.126 ± 0.027
Week 160.376 ± 0.0280.487 ± 0.0280.076 ± 0.029
Week 240.364 ± 0.0270.465 ± 0.0270.067 ± 0.029
Week 320.357 ± 0.0280.465 ± 0.0280.049 ± 0.029
Week 400.328 ± 0.0280.453 ± 0.0280.034 ± 0.029
Week 480.312 ± 0.0280.422 ± 0.0280.003 ± 0.029
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.310Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.419Tiotropium Respimat 10mcg - Placebo
SecondaryWeekly Mean Morning Pre-dose PEFRs

Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48
Reported as:
Mean · Litres/minute
Weekly Mean Morning Pre-dose PEFRs
Litres/minuteTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 2255.4 ± 1.8261.5 ± 1.8235.4 ± 1.9
Week 8259.0 ± 2.5265.6 ± 2.5241.8 ± 2.7
Week 16262.7 ± 3.0269.0 ± 3.0241.1 ± 3.1
Week 24265.7 ± 3.2270.1 ± 3.2244.3 ± 3.3
Week 32267.2 ± 3.4275.1 ± 3.4244.7 ± 3.6
Week 40267.0 ± 3.4276.7 ± 3.4247.4 ± 3.6
Week 48268.5 ± 3.6279.0 ± 3.6245.9 ± 3.8
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 22.5Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 33.1Tiotropium Respimat 10mcg - Placebo
SecondaryWeekly Mean Evening PEFRs

Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48
Reported as:
Mean · Litres/minute
Weekly Mean Evening PEFRs
Litres/minuteTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 2270.6 ± 2.0279.2 ± 2.0249.3 ± 2.1
Week 8274.5 ± 2.7282.1 ± 2.7253.4 ± 2.9
Week 16278.0 ± 3.1284.1 ± 3.1252.7 ± 3.2
Week 24280.0 ± 3.3287.0 ± 3.3254.7 ± 3.4
Week 32281.8 ± 3.4290.6 ± 3.4255.0 ± 3.6
Week 40283.1 ± 3.6292.2 ± 3.6257.1 ± 3.7
Week 48282.5 ± 3.9292.5 ± 3.9257.0 ± 4.1
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 25.5Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 35.5Tiotropium Respimat 10mcg - Placebo
SecondaryWeekly Mean Number of Puffs of Rescue Medication Per Day

Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.

Time frame:
Weeks 2, 8, 16, 24, 32, 40, 48
Reported as:
Mean · Puffs
Weekly Mean Number of Puffs of Rescue Medication Per Day
PuffsTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Week 21.9 ± 0.11.9 ± 0.12.7 ± 0.1
Week 82.0 ± 0.12.0 ± 0.12.7 ± 0.1
Week 162.1 ± 0.12.0 ± 0.12.8 ± 0.1
Week 242.1 ± 0.12.2 ± 0.13.0 ± 0.1
Week 322.2 ± 0.12.2 ± 0.13.0 ± 0.1
Week 402.2 ± 0.12.2 ± 0.13.0 ± 0.1
Week 482.3 ± 0.12.2 ± 0.13.1 ± 0.1
Statistical analysis
  • Tiotropium Respimat 5mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): -0.8Tiotropium Respimat 5mcg - Placebo
  • Tiotropium Respimat 10mcg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): -0.9Tiotropium Respimat 10mcg - Placebo
SecondaryMahler TDI Scores

Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value. Worst score = -3, best score = +3

Time frame:
Week 48
Reported as:
Mean · Points on a scale
Mahler TDI Scores
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Functional Impairment0.606 ± 0.0490.679 ± 0.0500.255 ± 0.053
Magnitude of Task0.650 ± 0.0520.673 ± 0.0520.291 ± 0.056
Magnitude of Effort0.633 ± 0.0560.706 ± 0.0560.240 ± 0.060
SecondarySaint George's Respiratory Questionnaire (SGRQ) Scores

Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0. The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
Week 48
Reported as:
Mean · Points on a scale
Saint George's Respiratory Questionnaire (SGRQ) Scores
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Symptoms42.323 ± 1.06441.798 ± 1.07047.835 ± 1.146
Activities56.317 ± 0.82355.180 ± 0.82858.629 ± 0.887
Impacts29.413 ± 0.74328.054 ± 0.74732.466 ± 0.801
SecondaryCOPD Symptoms Scores

COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
Week 48
Reported as:
Mean · Points on a scale
COPD Symptoms Scores
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Wheezing0.67 ± 0.040.65 ± 0.040.91 ± 0.04
Shortness of Breath1.35 ± 0.041.31 ± 0.041.51 ± 0.04
Coughing1.05 ± 0.041.04 ± 0.041.21 ± 0.04
Tightness of Chest0.61 ± 0.040.50 ± 0.040.78 ± 0.04
SecondaryPGE Scores

Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1-2 = Poor, 3-4 = Fair, 5-6 = Good, 7-8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
Week 48
Reported as:
Mean · Points on a scale
PGE Scores
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
PGE Scores5.18 ± 0.065.18 ± 0.064.62 ± 0.06
SecondaryPGR Score

Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.

Time frame:
Week 48
Reported as:
Mean · Points on a scale
PGR Score
Points on a scaleTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
PGR Score3.05 ± 0.072.86 ± 0.073.52 ± 0.08

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Tiotropium Respimat 5mcg———
Tiotropium Respimat 10mcg———
Placebo———
Most frequent serious events
Showing 10 of 119
Most frequent serious events
EventTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Chronic obstructive airways disease exacerbatedRespiratory, thoracic and mediastinal disorders13/33211/33217/319
PneumoniaInfections and infestations6/3324/3320/319
DeathGeneral disorders0/3325/3322/319
Myocardial infarctionCardiac disorders1/3320/3323/319
Cardiac failureCardiac disorders3/3320/3320/319
Inguinal herniaGastrointestinal disorders0/3323/3320/319
Gastrointestinal haemorrhageGastrointestinal disorders1/3320/3322/319
CholelithiasisHepatobiliary disorders0/3321/3322/319
CellulitisInfections and infestations0/3321/3322/319
Lobar pneumoniaInfections and infestations0/3320/3322/319
Most frequent other events
Most frequent other events
EventTiotropium Respimat 5mcgTiotropium Respimat 10mcgPlacebo
Chronic obstructive airways disease exacerbatedRespiratory, thoracic and mediastinal disorders95/33294/332114/319
Dry mouthGastrointestinal disorders15/33244/3324/319
NasopharyngitisInfections and infestations41/33231/33230/319
Back painMusculoskeletal and connective tissue disorders18/33213/33215/319
CoughRespiratory, thoracic and mediastinal disorders14/33216/33216/319

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlaceboTotal
Mean65 ± 8.264.6 ± 8.464.7 ± 8.964.8 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Tiotropium Respimat 5mcgTiotropium Respimat 10mcgPlaceboTotal
Female898067236
Male243252252747
08

Study locations

73 sites
  • Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
  • Boehringer Ingelheim Investigational Site
    Pismo Beach, California, United States
  • Boehringer Ingelheim Investigational Site
    San Diego, California, United States
  • Boehringer Ingelheim Investigational Site
    Fort Collins, Colorado, United States
  • Boehringer Ingelheim Investigational Site
    Minneapolis, Minnesota, United States
  • Boehringer Ingelheim Investigational Site
    Larchmont, New York, United States
  • Boehringer Ingelheim Investigational Site
    Raleigh, North Carolina, United States
  • Boehringer Ingelheim Investigational Site
    Chattanooga, Tennessee, United States
  • Boehringer Ingelheim Investigational Site
    Harker Heights, Texas, United States
  • Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • Boehringer Ingelheim Investigational Site
    Fredericksburg, Virginia, United States
  • Boehringer Ingelheim Investigational Site
    Harrisonburg, Virginia, United States
  • Boehringer Ingelheim Investigational Site
    Toorak Gardens, South Australia, Australia
  • Boehringer Ingelheim Investigational Site
    Woodville, South Australia, Australia
  • Boehringer Ingelheim Investigational Site
    Clayton, Victoria, Australia
  • Boehringer Ingelheim Investigational Site
    Frankston, Victoria, Australia
  • Boehringer Ingelheim Investigational Site
    Perth, Western Australia, Australia
  • Boehringer Ingelheim Investigational Site
    Antwerpen, Belgium
  • Boehringer Ingelheim Investigational Site
    Brussel, Belgium
  • Boehringer Ingelheim Investigational Site
    Bruxelles, Belgium
  • Boehringer Ingelheim Investigational Site
    Genk, Belgium
  • Boehringer Ingelheim Investigational Site
    Gent, Belgium
  • Boehringer Ingelheim Investigational Site
    Liège, Belgium
  • Boehringer Ingelheim Investigational Site
    Wavre, Belgium
  • Boehringer Ingelheim Investigational Site
    Edmonton, Alberta, Canada
  • Boehringer Ingelheim Investigational Site
    Halifax, Nova Scotia, Canada
  • Boehringer Ingelheim Investigational Site
    Courtice, Ontario, Canada
  • Boehringer Ingelheim Investigational Site
    Mississauga, Ontario, Canada
  • Boehringer Ingelheim Investigational Site
    Ottawa, Ontario, Canada
  • Boehringer Ingelheim Investigational Site
    Toronto, Ontario, Canada
  • Boehringer Ingelheim Investigational Site
    Sainte-Foy, Quebec, Canada
  • Boehringer Ingelheim Investigational Site
    Angers, France
  • Boehringer Ingelheim Investigational Site
    Beuvry, France
  • Boehringer Ingelheim Investigational Site
    Cambrai, France
  • Boehringer Ingelheim Investigational Site
    Lille, France
  • Boehringer Ingelheim Investigational Site
    Metz cedex 01, France
  • Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • Boehringer Ingelheim Investigational Site
    Darmstadt, Germany
  • Boehringer Ingelheim Investigational Site
    Gelnhausen, Germany
  • Boehringer Ingelheim Investigational Site
    Kassel, Germany
  • Boehringer Ingelheim Investigational Site
    Rüdersdorf, Germany
  • Boehringer Ingelheim Investigational Site
    Athens, Greece
  • Boehringer Ingelheim Investigational Site
    Heraklion, Greece
  • Boehringer Ingelheim Investigational Site
    Larissa, Greece
  • Boehringer Ingelheim Investigational Site
    Maroussi, Athens, Greece
  • Boehringer Ingelheim Investigational Site
    Melissia-Athens, Greece
  • Boehringer Ingelheim Investigational Site
    Breda, Netherlands
  • Boehringer Ingelheim Investigational Site
    Dordrecht, Netherlands
  • Boehringer Ingelheim Investigational Site
    Groningen, Netherlands
  • Boehringer Ingelheim Investigational Site
    Harderwijk, Netherlands
  • Boehringer Ingelheim Investigational Site
    Heerlen, Netherlands
  • Boehringer Ingelheim Investigational Site
    Zutphen, Netherlands
  • Boehringer Ingelheim Investigational Site
    Oslo, Norway
  • Boehringer Ingelheim Investigational Site
    Trondheim, Norway
  • Boehringer Ingelheim Investigational Site
    Ålesund, Norway
  • Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • Boehringer Ingelheim Investigational Site
    Alicante, Spain
  • Boehringer Ingelheim Investigational Site
    Las Palmas de Gran Canaria, Spain
  • Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • Boehringer Ingelheim Investigational Site
    Vic (Barcelona), Spain
  • Boehringer Ingelheim Investigational Site
    Motala, Sweden
  • Boehringer Ingelheim Investigational Site
    Skövde, Sweden
  • Boehringer Ingelheim Investigational Site
    Uppsala, Sweden
  • Boehringer Ingelheim Investigational Site
    Varberg, Sweden
  • Boehringer Ingelheim Investigational Site
    Ankara, Turkey
  • Boehringer Ingelheim Investigational Site
    Bursa, Turkey
  • Boehringer Ingelheim Investigational Site
    Istanbul, Turkey
  • Boehringer Ingelheim Investigational Site
    Birmingham, United Kingdom
  • Boehringer Ingelheim Investigational Site
    Bristol, United Kingdom
  • Boehringer Ingelheim Investigational Site
    Nottingham, United Kingdom
  • Boehringer Ingelheim Investigational Site
    Sheffield, United Kingdom
  • Boehringer Ingelheim Investigational Site
    Swansea, United Kingdom
  • Boehringer Ingelheim Investigational Site
    Torquay, United Kingdom
09

References and documents

Publications

  • Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1. PubMed 32943047 ↗
  • Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11. PubMed 25496316 ↗
  • Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat(R) Soft Mist Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26. PubMed 21814460 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00168844
Lead sponsor
Boehringer Ingelheim
First posted
Sep 15, 2005
Start date
Jan 2003
Primary completion
Jun 2005
Results posted
Oct 7, 2009
Last update
May 20, 2014

Study contacts

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

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