- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168844
Tiotropium / Respimat One-Year Study
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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South Australia
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Toorak Gardens, South Australia, Australia
- Boehringer Ingelheim Investigational Site
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Woodville, South Australia, Australia
- Boehringer Ingelheim Investigational Site
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Victoria
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Clayton, Victoria, Australia
- Boehringer Ingelheim Investigational Site
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Frankston, Victoria, Australia
- Boehringer Ingelheim Investigational Site
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Western Australia
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Perth, Western Australia, Australia
- Boehringer Ingelheim Investigational Site
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Antwerpen, Belgium
- Boehringer Ingelheim Investigational Site
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Brussel, Belgium
- Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
- Boehringer Ingelheim Investigational Site
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Genk, Belgium
- Boehringer Ingelheim Investigational Site
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Gent, Belgium
- Boehringer Ingelheim Investigational Site
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Liège, Belgium
- Boehringer Ingelheim Investigational Site
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Wavre, Belgium
- Boehringer Ingelheim Investigational Site
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Alberta
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Edmonton, Alberta, Canada
- Boehringer Ingelheim Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Boehringer Ingelheim Investigational Site
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Ontario
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Courtice, Ontario, Canada
- Boehringer Ingelheim Investigational Site
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Mississauga, Ontario, Canada
- Boehringer Ingelheim Investigational Site
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Ottawa, Ontario, Canada
- Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
- Boehringer Ingelheim Investigational Site
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Quebec
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Sainte-Foy, Quebec, Canada
- Boehringer Ingelheim Investigational Site
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Angers, France
- Boehringer Ingelheim Investigational Site
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Beuvry, France
- Boehringer Ingelheim Investigational Site
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Cambrai, France
- Boehringer Ingelheim Investigational Site
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Lille, France
- Boehringer Ingelheim Investigational Site
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Metz cedex 01, France
- Boehringer Ingelheim Investigational Site
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Berlin, Germany
- Boehringer Ingelheim Investigational Site
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Darmstadt, Germany
- Boehringer Ingelheim Investigational Site
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Gelnhausen, Germany
- Boehringer Ingelheim Investigational Site
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Kassel, Germany
- Boehringer Ingelheim Investigational Site
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Rüdersdorf, Germany
- Boehringer Ingelheim Investigational Site
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Athens, Greece
- Boehringer Ingelheim Investigational Site
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Heraklion, Greece
- Boehringer Ingelheim Investigational Site
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Larissa, Greece
- Boehringer Ingelheim Investigational Site
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Maroussi, Athens, Greece
- Boehringer Ingelheim Investigational Site
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Melissia-Athens, Greece
- Boehringer Ingelheim Investigational Site
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Breda, Netherlands
- Boehringer Ingelheim Investigational Site
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Dordrecht, Netherlands
- Boehringer Ingelheim Investigational Site
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Groningen, Netherlands
- Boehringer Ingelheim Investigational Site
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Harderwijk, Netherlands
- Boehringer Ingelheim Investigational Site
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Heerlen, Netherlands
- Boehringer Ingelheim Investigational Site
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Zutphen, Netherlands
- Boehringer Ingelheim Investigational Site
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Oslo, Norway
- Boehringer Ingelheim Investigational Site
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Trondheim, Norway
- Boehringer Ingelheim Investigational Site
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Ålesund, Norway
- Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
- Boehringer Ingelheim Investigational Site
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Alicante, Spain
- Boehringer Ingelheim Investigational Site
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Las Palmas de Gran Canaria, Spain
- Boehringer Ingelheim Investigational Site
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Madrid, Spain
- Boehringer Ingelheim Investigational Site
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Vic (Barcelona), Spain
- Boehringer Ingelheim Investigational Site
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Motala, Sweden
- Boehringer Ingelheim Investigational Site
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Skövde, Sweden
- Boehringer Ingelheim Investigational Site
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Uppsala, Sweden
- Boehringer Ingelheim Investigational Site
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Varberg, Sweden
- Boehringer Ingelheim Investigational Site
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Ankara, Turkey
- Boehringer Ingelheim Investigational Site
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Bursa, Turkey
- Boehringer Ingelheim Investigational Site
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Istanbul, Turkey
- Boehringer Ingelheim Investigational Site
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Birmingham, United Kingdom
- Boehringer Ingelheim Investigational Site
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Bristol, United Kingdom
- Boehringer Ingelheim Investigational Site
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Nottingham, United Kingdom
- Boehringer Ingelheim Investigational Site
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Sheffield, United Kingdom
- Boehringer Ingelheim Investigational Site
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Swansea, United Kingdom
- Boehringer Ingelheim Investigational Site
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Torquay, United Kingdom
- Boehringer Ingelheim Investigational Site
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California
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Los Angeles, California, United States
- Boehringer Ingelheim Investigational Site
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Pismo Beach, California, United States
- Boehringer Ingelheim Investigational Site
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San Diego, California, United States
- Boehringer Ingelheim Investigational Site
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Colorado
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Fort Collins, Colorado, United States
- Boehringer Ingelheim Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States
- Boehringer Ingelheim Investigational Site
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New York
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Larchmont, New York, United States
- Boehringer Ingelheim Investigational Site
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North Carolina
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Raleigh, North Carolina, United States
- Boehringer Ingelheim Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States
- Boehringer Ingelheim Investigational Site
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Texas
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Harker Heights, Texas, United States
- Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- Boehringer Ingelheim Investigational Site
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Virginia
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Fredericksburg, Virginia, United States
- Boehringer Ingelheim Investigational Site
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Harrisonburg, Virginia, United States
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Placebo
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Other: Tiotropium Respimat 5mcg (Tio R5)
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Other: Tiotropium Respimat 10mcg (Tio R10)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Time Frame: Week 48
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Rating scale of 3 domains - symptoms, activities and impact (weighted).
Worst score = 100, best score = 0
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Week 48
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TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
Time Frame: Week 48
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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. |
Week 48
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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
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Trough Forced Expiratory Volume in 1 second (FEV1)
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10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
Time Frame: 48 weeks
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Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined. |
48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Heart Rate
Time Frame: Baseline to Week 40 pre-dose
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Week 40 pre-dose - baseline
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Baseline to Week 40 pre-dose
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Change From Baseline in PR Interval
Time Frame: Baseline to Week 40 pre-dose
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Baseline to Week 40 pre-dose
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Change From Baseline in QRS Interval
Time Frame: Baseline to Week 40 pre-dose
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Week 40 pre-dose - baseline
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Baseline to Week 40 pre-dose
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Change From Baseline in QT Interval
Time Frame: Baseline to Week 40 pre-dose
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Week 40 pre-dose - baseline
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Baseline to Week 40 pre-dose
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Change From Baseline in QT Interval (Bazett)
Time Frame: Baseline to Week 40 pre-dose
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Week 40 pre-dose - baseline
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Baseline to Week 40 pre-dose
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Change From Baseline in QT Interval (Fridericia)
Time Frame: Baseline to Week 40 pre-dose
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Week 40 pre-dose - baseline
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Baseline to Week 40 pre-dose
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Change From Baseline in Heart Rate
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in Supraventricular Premature Beat (SVPB) Total
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in SVPB Pairs
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in Ventricular Premature Beat (VPB) Total
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in VPB Pairs
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in Haemoglobin
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Red Blood Cell Count
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in White Blood Cell Count
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Platelets
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Neutrophils
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Eosinophils
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Basophils
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Lymphocytes
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Monocytes
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Neutrophils (Absolute)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Eosinophils (Absolute)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Basophils (Absolute)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Lymphocytes (Absolute)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Monocytes (Absolute)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Calcium
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Phosphate
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Alkaline Phosphatase
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Glucose
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Urea
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Blood Urea Nitrogen
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Creatinine
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Bilirubin, Total
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Uric Acid
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Protein, Total
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Albumin
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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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
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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.
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10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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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
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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.
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10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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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
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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.
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10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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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
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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.
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10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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Weekly Mean Morning Pre-dose PEFRs
Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48
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Weekly mean morning pre-dose peak expiratory flow rates (PEFRs).
The means are adjusted for centre, smoking status at entry, and baseline value.
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Weeks 2, 8, 16, 24, 32, 40, 48
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Weekly Mean Number of Puffs of Rescue Medication Per Day
Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48
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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.
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Weeks 2, 8, 16, 24, 32, 40, 48
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Mahler TDI Scores
Time Frame: Week 48
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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 |
Week 48
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Saint George's Respiratory Questionnaire (SGRQ) Scores
Time Frame: Week 48
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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. |
Week 48
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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
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in VPB Run Events
Time Frame: Baseline to Week 40
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Week 40 - baseline
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Baseline to Week 40
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Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood
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Baseline to Week 48 or at premature discontinuation if before Week 48
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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
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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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
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Change From Baseline in Lactic Dehydrogenase (LDH)
Time Frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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Week 48 - baseline
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Baseline to Week 48 or at premature discontinuation if before Week 48
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Weekly Mean Evening PEFRs
Time Frame: Weeks 2, 8, 16, 24, 32, 40, 48
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Weekly mean evening peak expiratory flow rates (PEFRs).
The means are adjusted for centre, smoking status at entry, and baseline value.
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Weeks 2, 8, 16, 24, 32, 40, 48
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COPD Symptoms Scores
Time Frame: Week 48
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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. |
Week 48
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PGE Scores
Time Frame: Week 48
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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. |
Week 48
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PGR Score
Time Frame: Week 48
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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. |
Week 48
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 205.254
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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