To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,007
Change From Baseline in Trough FEV1 After 48 Weeks
Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 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
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
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
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
Change From Baseline in Heart Rate
Week 40 pre-dose - baseline
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in PR Interval
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QRS Interval
Week 40 pre-dose - baseline
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Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
La Jolla, California, United States
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
San Luis Obispo, California, United States
Boehringer Ingelheim Investigational Site
Gainesville, Florida, United States
Boehringer Ingelheim Investigational Site
Hallandale, Florida, United States
Boehringer Ingelheim Investigational Site
Hines, Illinois, United States
Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
Boehringer Ingelheim Investigational Site
Bay Shore, New York, United States
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
...and 66 more locations
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval
Week 40 pre-dose - baseline
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Bazett)
Week 40 pre-dose - baseline
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Fridericia)
Week 40 pre-dose - baseline
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in Heart Rate
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in Supraventricular Premature Beat (SVPB) Total
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in SVPB Run Events
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in SVPB Pairs
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Total
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Run Events
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in VPB Pairs
Week 40 - baseline
Time frame: Baseline to Week 40
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Haemoglobin
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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
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
Change From Baseline in Platelets
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils (Absolute)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils (Absolute)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils (Absolute)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes (Absolute)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes (Absolute)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Calcium
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Phosphate
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Alkaline Phosphatase
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lactic Dehyrogenase (LDH)
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Glucose
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Urea
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Blood Urea Nitrogen
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Creatinine
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Bilirubin, Total
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Uric Acid
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Protein, Total
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Albumin
Week 48 - baseline
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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
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
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
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
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
Weekly Mean Morning 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
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
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
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
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
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
PGR Scores
Patient's Global rating (PGR) scores 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