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Completed

NCT Number: NCT00168844

Tiotropium / Respimat One-Year Study

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boehringer Ingelheim Investigational Site, Toorak Gardens, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

Tiotropium Inhalation Solution

Drug

Placebo

Other

Primary outcomes

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

    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

    Trough Forced Expiratory Volume in 1 second (FEV1)

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

    Time frame: Week 48

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

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

    Time frame: Week 48

    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.

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

    Time frame: 48 weeks

    Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.

    For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

Secondary outcomes

  1. Change From Baseline in Heart Rate

    Time frame: Baseline to Week 40 pre-dose

    Week 40 pre-dose - baseline

  2. Change From Baseline in PR Interval

    Time frame: Baseline to Week 40 pre-dose

  3. Change From Baseline in QRS Interval

    Time frame: Baseline to Week 40 pre-dose

    Week 40 pre-dose - baseline

  4. Change From Baseline in QT Interval

    Time frame: Baseline to Week 40 pre-dose

    Week 40 pre-dose - baseline

  5. Change From Baseline in QT Interval (Bazett)

    Time frame: Baseline to Week 40 pre-dose

    Week 40 pre-dose - baseline

  6. Change From Baseline in QT Interval (Fridericia)

    Time frame: Baseline to Week 40 pre-dose

    Week 40 pre-dose - baseline

  7. Change From Baseline in Heart Rate

    Time frame: Baseline to Week 40

    Week 40 - baseline

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

    Time frame: Baseline to Week 40

    Week 40 - baseline

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

    Time frame: Baseline to Week 40

    Week 40 - baseline

  10. Change From Baseline in SVPB Pairs

    Time frame: Baseline to Week 40

    Week 40 - baseline

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

    Time frame: Baseline to Week 40

    Week 40 - baseline

  12. Change From Baseline in VPB Run Events

    Time frame: Baseline to Week 40

    Week 40 - baseline

  13. Change From Baseline in VPB Pairs

    Time frame: Baseline to Week 40

    Week 40 - baseline

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

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

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

  15. Change From Baseline in Haemoglobin

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

    Week 48 - baseline

  16. Change From Baseline in Red Blood Cell Count

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

    Week 48 - baseline

  17. Change From Baseline in White Blood Cell Count

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

    Week 48 - baseline

  18. Change From Baseline in Platelets

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

    Week 48 - baseline

  19. Change From Baseline in Neutrophils

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

    Week 48 - baseline

  20. Change From Baseline in Eosinophils

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

    Week 48 - baseline

  21. Change From Baseline in Basophils

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

    Week 48 - baseline

  22. Change From Baseline in Lymphocytes

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

    Week 48 - baseline

  23. Change From Baseline in Monocytes

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

    Week 48 - baseline

  24. Change From Baseline in Neutrophils (Absolute)

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

    Week 48 - baseline

  25. Change From Baseline in Lymphocytes (Absolute)

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

    Week 48 - baseline

  26. Change From Baseline in Eosinophils (Absolute)

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

    Week 48 - baseline

  27. Change From Baseline in Basophils (Absolute)

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

    Week 48 - baseline

  28. Change From Baseline in Monocytes (Absolute)

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

    Week 48 - baseline

  29. Change From Baseline in Calcium

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

    Week 48 - baseline

  30. Change From Baseline in Phosphate

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

    Week 48 - baseline

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

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

    Week 48 - baseline

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

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

    Week 48 - baseline

  33. Change From Baseline in Alkaline Phosphatase

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

    Week 48 - baseline

  34. Change From Baseline in Lactic Dehydrogenase (LDH)

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

    Week 48 - baseline

  35. Change From Baseline in Glucose

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

    Week 48 - baseline

  36. Change From Baseline in Urea

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

    Week 48 - baseline

  37. Change From Baseline in Blood Urea Nitrogen

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

    Week 48 - baseline

  38. Change From Baseline in Creatinine

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

    Week 48 - baseline

  39. Change From Baseline in Bilirubin, Total

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

    Week 48 - baseline

  40. Change From Baseline in Uric Acid

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

    Week 48 - baseline

  41. Change From Baseline in Protein, Total

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

    Week 48 - baseline

  42. Change From Baseline in Albumin

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

    Week 48 - baseline

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

    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

    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.

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

    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

    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.

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

    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

    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.

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

    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

    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.

  47. Weekly Mean Morning Pre-dose PEFRs

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

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

  48. Weekly Mean Evening PEFRs

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

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

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

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

    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.

  50. Mahler TDI Scores

    Time frame: Week 48

    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

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

    Time frame: Week 48

    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.

  52. COPD Symptoms Scores

    Time frame: Week 48

    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.

  53. PGE Scores

    Time frame: Week 48

    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.

  54. PGR Score

    Time frame: Week 48

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2003
Primary completion
2005
First posted
Sep 15, 2005
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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