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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00168831




Registration number
NCT00168831
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
205.255
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 After 48 Weeks - Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks
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
Change From Baseline in 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 Ventricular Premature Beat (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)
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 Eosinophils (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 Basophils (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 Lymphocytes (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/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (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/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (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 Dehyrogenase (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 Morning 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 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.
Timepoint [54] 0 0
Week 48

Eligibility
Key inclusion criteria
Criteria

- Patients with stable moderate to severe COPD and a smoking history of at least 10 pack
years were eligible for inclusion in the study. Patients with significant diseases
other than COPD were excluded as were patients with a recent history of myocardial
infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia,
narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with
cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids
were ineligible for inclusion in the study as were patients who had received previous
treatment with tiotropium.
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)
ACT,SA,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Garran
Recruitment hospital [2] 0 0
Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Innsbruck
Country [11] 0 0
Austria
State/province [11] 0 0
Mittersill
Country [12] 0 0
Austria
State/province [12] 0 0
Schwechat
Country [13] 0 0
Austria
State/province [13] 0 0
Wels
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Finland
State/province [18] 0 0
Espoo
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
Finland
State/province [20] 0 0
Lahti
Country [21] 0 0
Finland
State/province [21] 0 0
Lappeenranta
Country [22] 0 0
Finland
State/province [22] 0 0
Lohja
Country [23] 0 0
France
State/province [23] 0 0
Amboise cedex
Country [24] 0 0
France
State/province [24] 0 0
Chauny
Country [25] 0 0
France
State/province [25] 0 0
Marseille cedex 06
Country [26] 0 0
France
State/province [26] 0 0
Metz cedex 01
Country [27] 0 0
France
State/province [27] 0 0
Montpellier
Country [28] 0 0
France
State/province [28] 0 0
Nantes
Country [29] 0 0
Greece
State/province [29] 0 0
Alexandroupolis
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Mournies-Chania
Country [32] 0 0
Greece
State/province [32] 0 0
Trikala
Country [33] 0 0
Ireland
State/province [33] 0 0
Dublin 4
Country [34] 0 0
Ireland
State/province [34] 0 0
Dublin 7
Country [35] 0 0
Ireland
State/province [35] 0 0
Dublin
Country [36] 0 0
Italy
State/province [36] 0 0
Bologna
Country [37] 0 0
Italy
State/province [37] 0 0
Bussolengo (vr)
Country [38] 0 0
Italy
State/province [38] 0 0
Cava dei tirreni (SA)
Country [39] 0 0
Italy
State/province [39] 0 0
Crema (CR)
Country [40] 0 0
Italy
State/province [40] 0 0
Genova
Country [41] 0 0
Italy
State/province [41] 0 0
Milano
Country [42] 0 0
Italy
State/province [42] 0 0
Pistoia
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Italy
State/province [44] 0 0
Salerno
Country [45] 0 0
Italy
State/province [45] 0 0
Sesto San Giovanni (Milano)
Country [46] 0 0
Netherlands
State/province [46] 0 0
Arnhem
Country [47] 0 0
Netherlands
State/province [47] 0 0
Eindhoven
Country [48] 0 0
Netherlands
State/province [48] 0 0
Heerenveen
Country [49] 0 0
Netherlands
State/province [49] 0 0
Hoorn
Country [50] 0 0
Netherlands
State/province [50] 0 0
Leeuwarden
Country [51] 0 0
Netherlands
State/province [51] 0 0
Rotterdam
Country [52] 0 0
New Zealand
State/province [52] 0 0
Auckland
Country [53] 0 0
New Zealand
State/province [53] 0 0
Hamilton
Country [54] 0 0
Russian Federation
State/province [54] 0 0
St. Petersburg
Country [55] 0 0
South Africa
State/province [55] 0 0
Bellville
Country [56] 0 0
South Africa
State/province [56] 0 0
Cape Town
Country [57] 0 0
South Africa
State/province [57] 0 0
George
Country [58] 0 0
South Africa
State/province [58] 0 0
Johannesburg
Country [59] 0 0
South Africa
State/province [59] 0 0
Vanderbijlpark
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Centelles
Country [62] 0 0
Spain
State/province [62] 0 0
Murcia
Country [63] 0 0
Spain
State/province [63] 0 0
Sant Boi de Llobregat (Barcelona)
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Babbacombe
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cottingham
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Isleworth
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Manchester
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Plymouth
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sunderland

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/NCT00168831
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