Tiotropium / Respimat One-Year Study

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium Inhalation Solution
Other: Placebo

Registration Number: NCT00168831

Lead Sponsor: Boehringer Ingelheim

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1007

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium Respimat 5mcg (Tio R5)	Tiotropium Inhalation Solution	-
Tiotropium Respimat 10mcg (Tio R10)	Tiotropium Inhalation Solution	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough FEV1 After 48 Weeks	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 48 weeks
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)	Week 48	Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)	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.
COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)	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 Outcome Measures

Name	Time	Method
Change From Baseline in QT Interval	Baseline to Week 40 pre-dose	Week 40 pre-dose - baseline
Change From Baseline in Eosinophils (Absolute)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Heart Rate	Baseline to Week 40	Week 40 - baseline
Change From Baseline in PR Interval	Baseline to Week 40 pre-dose
Change From Baseline in QRS Interval	Baseline to Week 40 pre-dose	Week 40 pre-dose - baseline
Change From Baseline in QT Interval (Bazett)	Baseline to Week 40 pre-dose	Week 40 pre-dose - baseline
Change From Baseline in QT Interval (Fridericia)	Baseline to Week 40 pre-dose	Week 40 pre-dose - baseline
Change From Baseline in Supraventricular Premature Beat (SVPB) Total	Baseline to Week 40	Week 40 - baseline
Change From Baseline in SVPB Run Events	Baseline to Week 40	Week 40 - baseline
Change From Baseline in SVPB Pairs	Baseline to Week 40	Week 40 - baseline
Change From Baseline in Ventricular Premature Beat (VPB) Total	Baseline to Week 40	Week 40 - baseline
Change From Baseline in Ventricular Premature Beat (VPB) Run Events	Baseline to Week 40	Week 40 - baseline
Change From Baseline in VPB Pairs	Baseline to Week 40	Week 40 - baseline
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)	Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Haemoglobin	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Red Blood Cell Count	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in White Blood Cell Count	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Platelets	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Neutrophils	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Eosinophils	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Basophils	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Lymphocytes	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Monocytes	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Neutrophils (Absolute)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Basophils (Absolute)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Lymphocytes (Absolute)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Monocytes (Absolute)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Calcium	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Phosphate	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Alkaline Phosphatase	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Lactic Dehyrogenase (LDH)	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Glucose	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Urea	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Blood Urea Nitrogen	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Creatinine	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Bilirubin, Total	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Uric Acid	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Protein, Total	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Albumin	Baseline to Week 48 or at premature discontinuation if before Week 48	Week 48 - baseline
Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks	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.
Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks	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.
Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	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.
Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	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.
Weekly Mean Morning Pre-dose PEFRs	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.
Weekly Mean Morning Evening PEFRs	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.
Weekly Mean Number of Puffs of Rescue Medication Per Day	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.
Mahler TDI Scores	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
Saint George's Respiratory Questionnaire (SGRQ) Scores	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.
COPD Symptoms Scores	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.
PGE Scores	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.
PGR Scores	Week 48	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.