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Clinical Trials/NCT00168831
NCT00168831CompletedPhase 3

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)

Boehringer Ingelheim2 sites in 2 countries1,007 target enrollmentStarted: February 2003Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,007
Locations
2
Primary Endpoint
Change From Baseline in Trough FEV1 After 48 Weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Tiotropium Respimat 5mcg (Tio R5)

Other

Intervention: Tiotropium Inhalation Solution (Drug)

Tiotropium Respimat 10mcg (Tio R10)

Other

Intervention: Tiotropium Inhalation Solution (Drug)

Placebo

Other

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Change From Baseline in Trough 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

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)

Time Frame: Week 48

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

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.

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.

Secondary Outcomes

  • Change From Baseline in Heart Rate(Baseline to Week 40)
  • Change From Baseline in PR Interval(Baseline to Week 40 pre-dose)
  • Change From Baseline in Neutrophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in QRS Interval(Baseline to Week 40 pre-dose)
  • Change From Baseline in QT Interval(Baseline to Week 40 pre-dose)
  • Change From Baseline in QT Interval (Bazett)(Baseline to Week 40 pre-dose)
  • Change From Baseline in QT Interval (Fridericia)(Baseline to Week 40 pre-dose)
  • Change From Baseline in Supraventricular Premature Beat (SVPB) Total(Baseline to Week 40)
  • Change From Baseline in SVPB Run Events(Baseline to Week 40)
  • Change From Baseline in SVPB Pairs(Baseline to Week 40)
  • Change From Baseline in Ventricular Premature Beat (VPB) Total(Baseline to Week 40)
  • Change From Baseline in Ventricular Premature Beat (VPB) Run Events(Baseline to Week 40)
  • Change From Baseline in VPB Pairs(Baseline to Week 40)
  • 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)
  • Change From Baseline in Red Blood Cell Count(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in White Blood Cell Count(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Platelets(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Eosinophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Basophils(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Lymphocytes(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Monocytes(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Neutrophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Eosinophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Basophils (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Lymphocytes (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Monocytes (Absolute)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Calcium(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Phosphate(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)(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)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Alkaline Phosphatase(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Lactic Dehyrogenase (LDH)(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Glucose(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Urea(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Blood Urea Nitrogen(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Creatinine(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Bilirubin, Total(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Uric Acid(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Protein, Total(Baseline to Week 48 or at premature discontinuation if before Week 48)
  • Change From Baseline in Albumin(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(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(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(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(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(Weeks 2, 8, 16, 24, 32, 40, 48)
  • Weekly Mean Morning Evening PEFRs(Weeks 2, 8, 16, 24, 32, 40, 48)
  • Weekly Mean Number of Puffs of Rescue Medication Per Day(Weeks 2, 8, 16, 24, 32, 40, 48)
  • Mahler TDI Scores(Week 48)
  • Saint George's Respiratory Questionnaire (SGRQ) Scores(Week 48)
  • COPD Symptoms Scores(Week 48)
  • PGE Scores(Week 48)
  • PGR Scores(Week 48)

Investigators

Sponsor Class
Industry

Study Sites (2)

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