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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00168844




Registration number
NCT00168844
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
20/05/2014

Titles & IDs
Public title
Tiotropium / Respimat One-Year Study
Scientific 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)
Secondary ID [1] 0 0
205.254
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tiotropium Inhalation Solution
Other interventions - Placebo

Other: Tiotropium Respimat 5mcg (Tio R5) -

Other: Tiotropium Respimat 10mcg (Tio R10) -

Other: Placebo -


Treatment: Drugs: Tiotropium Inhalation Solution


Other interventions: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) - Trough Forced Expiratory Volume in 1 second (FEV1)
Timepoint [1] 0 0
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 48
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 48
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
48 weeks
Secondary outcome [1] 0 0
Change From Baseline in Heart Rate - Week 40 pre-dose - baseline
Timepoint [1] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [2] 0 0
Change From Baseline in PR Interval
Timepoint [2] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [3] 0 0
Change From Baseline in QRS Interval - Week 40 pre-dose - baseline
Timepoint [3] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [4] 0 0
Change From Baseline in QT Interval - Week 40 pre-dose - baseline
Timepoint [4] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [5] 0 0
Change From Baseline in QT Interval (Bazett) - Week 40 pre-dose - baseline
Timepoint [5] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [6] 0 0
Change From Baseline in QT Interval (Fridericia) - Week 40 pre-dose - baseline
Timepoint [6] 0 0
Baseline to Week 40 pre-dose
Secondary outcome [7] 0 0
Change From Baseline in Heart Rate - Week 40 - baseline
Timepoint [7] 0 0
Baseline to Week 40
Secondary outcome [8] 0 0
Change From Baseline in Supraventricular Premature Beat (SVPB) Total - Week 40 - baseline
Timepoint [8] 0 0
Baseline to Week 40
Secondary outcome [9] 0 0
Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events - Week 40 - baseline
Timepoint [9] 0 0
Baseline to Week 40
Secondary outcome [10] 0 0
Change From Baseline in SVPB Pairs - Week 40 - baseline
Timepoint [10] 0 0
Baseline to Week 40
Secondary outcome [11] 0 0
Change From Baseline in Ventricular Premature Beat (VPB) Total - Week 40 - baseline
Timepoint [11] 0 0
Baseline to Week 40
Secondary outcome [12] 0 0
Change From Baseline in VPB Run Events - Week 40 - baseline
Timepoint [12] 0 0
Baseline to Week 40
Secondary outcome [13] 0 0
Change From Baseline in VPB Pairs - Week 40 - baseline
Timepoint [13] 0 0
Baseline to Week 40
Secondary outcome [14] 0 0
Change From Baseline in Haematocrit, Packed Cell Volume (PCV) - Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood
Timepoint [14] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [15] 0 0
Change From Baseline in Haemoglobin - Week 48 - baseline
Timepoint [15] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [16] 0 0
Change From Baseline in Red Blood Cell Count - Week 48 - baseline
Timepoint [16] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [17] 0 0
Change From Baseline in White Blood Cell Count - Week 48 - baseline
Timepoint [17] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [18] 0 0
Change From Baseline in Platelets - Week 48 - baseline
Timepoint [18] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [19] 0 0
Change From Baseline in Neutrophils - Week 48 - baseline
Timepoint [19] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [20] 0 0
Change From Baseline in Eosinophils - Week 48 - baseline
Timepoint [20] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [21] 0 0
Change From Baseline in Basophils - Week 48 - baseline
Timepoint [21] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [22] 0 0
Change From Baseline in Lymphocytes - Week 48 - baseline
Timepoint [22] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [23] 0 0
Change From Baseline in Monocytes - Week 48 - baseline
Timepoint [23] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [24] 0 0
Change From Baseline in Neutrophils (Absolute) - Week 48 - baseline
Timepoint [24] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [25] 0 0
Change From Baseline in Lymphocytes (Absolute) - Week 48 - baseline
Timepoint [25] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [26] 0 0
Change From Baseline in Eosinophils (Absolute) - Week 48 - baseline
Timepoint [26] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [27] 0 0
Change From Baseline in Basophils (Absolute) - Week 48 - baseline
Timepoint [27] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [28] 0 0
Change From Baseline in Monocytes (Absolute) - Week 48 - baseline
Timepoint [28] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [29] 0 0
Change From Baseline in Calcium - Week 48 - baseline
Timepoint [29] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [30] 0 0
Change From Baseline in Phosphate - Week 48 - baseline
Timepoint [30] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [31] 0 0
Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT) - Week 48 - baseline
Timepoint [31] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [32] 0 0
Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT) - Week 48 - baseline
Timepoint [32] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [33] 0 0
Change From Baseline in Alkaline Phosphatase - Week 48 - baseline
Timepoint [33] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [34] 0 0
Change From Baseline in Lactic Dehydrogenase (LDH) - Week 48 - baseline
Timepoint [34] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [35] 0 0
Change From Baseline in Glucose - Week 48 - baseline
Timepoint [35] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [36] 0 0
Change From Baseline in Urea - Week 48 - baseline
Timepoint [36] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [37] 0 0
Change From Baseline in Blood Urea Nitrogen - Week 48 - baseline
Timepoint [37] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [38] 0 0
Change From Baseline in Creatinine - Week 48 - baseline
Timepoint [38] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [39] 0 0
Change From Baseline in Bilirubin, Total - Week 48 - baseline
Timepoint [39] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [40] 0 0
Change From Baseline in Uric Acid - Week 48 - baseline
Timepoint [40] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [41] 0 0
Change From Baseline in Protein, Total - Week 48 - baseline
Timepoint [41] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [42] 0 0
Change From Baseline in Albumin - Week 48 - baseline
Timepoint [42] 0 0
Baseline to Week 48 or at premature discontinuation if before Week 48
Secondary outcome [43] 0 0
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.
Timepoint [43] 0 0
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Secondary outcome [44] 0 0
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.
Timepoint [44] 0 0
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Secondary outcome [45] 0 0
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.
Timepoint [45] 0 0
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Secondary outcome [46] 0 0
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.
Timepoint [46] 0 0
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Secondary outcome [47] 0 0
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.
Timepoint [47] 0 0
Weeks 2, 8, 16, 24, 32, 40, 48
Secondary outcome [48] 0 0
Weekly Mean Evening PEFRs - Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
Timepoint [48] 0 0
Weeks 2, 8, 16, 24, 32, 40, 48
Secondary outcome [49] 0 0
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.
Timepoint [49] 0 0
Weeks 2, 8, 16, 24, 32, 40, 48
Secondary outcome [50] 0 0
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
Timepoint [50] 0 0
Week 48
Secondary outcome [51] 0 0
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.
Timepoint [51] 0 0
Week 48
Secondary outcome [52] 0 0
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.
Timepoint [52] 0 0
Week 48
Secondary outcome [53] 0 0
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.
Timepoint [53] 0 0
Week 48
Secondary outcome [54] 0 0
PGR Score - 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.
Timepoint [54] 0 0
Week 48

Eligibility
Key inclusion criteria
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [2] 0 0
Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site - Frankston
Recruitment hospital [5] 0 0
Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Toorak Gardens
Recruitment postcode(s) [2] 0 0
- Woodville
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussel
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Genk
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Liège
Country [15] 0 0
Belgium
State/province [15] 0 0
Wavre
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Nova Scotia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Angers
Country [21] 0 0
France
State/province [21] 0 0
Beuvry
Country [22] 0 0
France
State/province [22] 0 0
Cambrai
Country [23] 0 0
France
State/province [23] 0 0
Lille
Country [24] 0 0
France
State/province [24] 0 0
Metz cedex 01
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Darmstadt
Country [27] 0 0
Germany
State/province [27] 0 0
Gelnhausen
Country [28] 0 0
Germany
State/province [28] 0 0
Kassel
Country [29] 0 0
Germany
State/province [29] 0 0
Rüdersdorf
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Heraklion
Country [32] 0 0
Greece
State/province [32] 0 0
Larissa
Country [33] 0 0
Greece
State/province [33] 0 0
Maroussi, Athens
Country [34] 0 0
Greece
State/province [34] 0 0
Melissia-Athens
Country [35] 0 0
Netherlands
State/province [35] 0 0
Breda
Country [36] 0 0
Netherlands
State/province [36] 0 0
Dordrecht
Country [37] 0 0
Netherlands
State/province [37] 0 0
Groningen
Country [38] 0 0
Netherlands
State/province [38] 0 0
Harderwijk
Country [39] 0 0
Netherlands
State/province [39] 0 0
Heerlen
Country [40] 0 0
Netherlands
State/province [40] 0 0
Zutphen
Country [41] 0 0
Norway
State/province [41] 0 0
Oslo
Country [42] 0 0
Norway
State/province [42] 0 0
Trondheim
Country [43] 0 0
Norway
State/province [43] 0 0
Ålesund
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moscow
Country [45] 0 0
Spain
State/province [45] 0 0
Alicante
Country [46] 0 0
Spain
State/province [46] 0 0
Las Palmas de Gran Canaria
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Vic (Barcelona)
Country [49] 0 0
Sweden
State/province [49] 0 0
Motala
Country [50] 0 0
Sweden
State/province [50] 0 0
Skövde
Country [51] 0 0
Sweden
State/province [51] 0 0
Uppsala
Country [52] 0 0
Sweden
State/province [52] 0 0
Varberg
Country [53] 0 0
Turkey
State/province [53] 0 0
Ankara
Country [54] 0 0
Turkey
State/province [54] 0 0
Bursa
Country [55] 0 0
Turkey
State/province [55] 0 0
Istanbul
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Birmingham
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Bristol
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Nottingham
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Sheffield
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Swansea
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the
Respimat inhaler in patients with COPD.
Trial website
https://clinicaltrials.gov/show/NCT00168844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications