Pulmonary Disease, Chronic ObstructivePhase 3NCT00168831
Tiotropium / Respimat One-Year Study
A Phase 3 study testing Tiotropium Inhalation Solution in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 76 sites in 15 countries.
Trial summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,007 participants
- Where
- 76 sitesin 15 countries
- Study dates
- Feb 2003to Jun 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
76 sites in 15 countries.
76 sites in 15 countries
United States12 sites
Boehringer Ingelheim Investigational Site
Bay Shore, New York
Boehringer Ingelheim Investigational Site
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
Boehringer Ingelheim Investigational Site
Gainesville, Florida
Boehringer Ingelheim Investigational Site
Hallandale, Florida
Boehringer Ingelheim Investigational Site
Hines, Illinois
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
La Jolla, California
Boehringer Ingelheim Investigational Site
Long Beach, California
Boehringer Ingelheim Investigational Site
Richmond, Virginia
Boehringer Ingelheim Investigational Site
San Luis Obispo, California
Italy10 sites
Boehringer Ingelheim Investigational Site
Bologna
Boehringer Ingelheim Investigational Site
Bussolengo (vr)
Boehringer Ingelheim Investigational Site
Cava Dei Tirreni (SA)
Boehringer Ingelheim Investigational Site
Crema (CR)
Boehringer Ingelheim Investigational Site
Genova
Boehringer Ingelheim Investigational Site
Milan
Boehringer Ingelheim Investigational Site
Pistoia
Boehringer Ingelheim Investigational Site
Roma
Boehringer Ingelheim Investigational Site
Salerno
Boehringer Ingelheim Investigational Site
Sesto San Giovanni (Milano)
Austria6 sites
Boehringer Ingelheim Investigational Site
Innsbruck
Boehringer Ingelheim Investigational Site
Mittersill
Boehringer Ingelheim Investigational Site
Schwechat
Baumgartner Hohe Otto Wagner Spital Wien
Vienna
Boehringer Ingelheim Investigational Site
Vienna
Boehringer Ingelheim Investigational Site
Wels
France6 sites
Boehringer Ingelheim Investigational Site
Amboise
Boehringer Ingelheim Investigational Site
Chauny
Boehringer Ingelheim Investigational Site
Marseille
Boehringer Ingelheim Investigational Site
Metz
Boehringer Ingelheim Investigational Site
Montpellier
Boehringer Ingelheim Investigational Site
Nantes
Netherlands6 sites
Boehringer Ingelheim Investigational Site
Arnhem
Boehringer Ingelheim Investigational Site
Eindhoven
Boehringer Ingelheim Investigational Site
Heerenveen
Boehringer Ingelheim Investigational Site
Hoorn
Boehringer Ingelheim Investigational Site
Leeuwarden
Boehringer Ingelheim Investigational Site
Rotterdam
United Kingdom6 sites
Boehringer Ingelheim Investigational Site
Babbacombe
Boehringer Ingelheim Investigational Site
Cottingham
Boehringer Ingelheim Investigational Site
Isleworth
Boehringer Ingelheim Investigational Site
Manchester
Boehringer Ingelheim Investigational Site
Plymouth
Boehringer Ingelheim Investigational Site
Sunderland
Canada5 sites
Boehringer Ingelheim Investigational Site
Hamilton, Ontario
Boehringer Ingelheim Investigational Site
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
Boehringer Ingelheim Investigational Site
Toronto, Ontario
Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
Finland5 sites
Boehringer Ingelheim Investigational Site
Espoo
Boehringer Ingelheim Investigational Site
Helsinki
Boehringer Ingelheim Investigational Site
Lahti
Boehringer Ingelheim Investigational Site
Lappeenranta
Boehringer Ingelheim Investigational Site
Lohja
South Africa5 sites
Boehringer Ingelheim Investigational Site
Bellville
Boehringer Ingelheim Investigational Site
Cape Town
Boehringer Ingelheim Investigational Site
George
Boehringer Ingelheim Investigational Site
Johannesburg
Boehringer Ingelheim Investigational Site
Vanderbijlpark
Greece4 sites
Boehringer Ingelheim Investigational Site
Alexandroupoli
Boehringer Ingelheim Investigational Site
Athens
Boehringer Ingelheim Investigational Site
Mournies-Chania
Boehringer Ingelheim Investigational Site
Trikala
Spain4 sites
Boehringer Ingelheim Investigational Site
Barcelona
Boehringer Ingelheim Investigational Site
Centelles
Boehringer Ingelheim Investigational Site
Murcia
Boehringer Ingelheim Investigational Site
Sant Boi de Llobregat (Barcelona)
Australia3 sites
Boehringer Ingelheim Investigational Site
Adelaide, South Australia
Boehringer Ingelheim Investigational Site
Garran, Australian Capital Territory
Boehringer Ingelheim Investigational Site
Nedlands, Western Australia
New Zealand2 sites
Boehringer Ingelheim Investigational Site
Auckland
Boehringer Ingelheim Investigational Site
Hamilton
About this study
Official 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)
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium Inhalation Solution, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Inhalation SolutionDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium Respimat 5mcg (Tio R5) | Other | Not described Receives: Drug: Tiotropium Inhalation Solution |
| Tiotropium Respimat 10mcg (Tio R10) | Other | Not described Receives: Drug: Tiotropium Inhalation Solution |
| Placebo | Other | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough FEV1 After 48 Weeks
Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks
Measured: 10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
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
Measured: Week 48
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.
Measured: Week 48
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.
Measured: 48 weeks
Secondary outcomes (54)
Change From Baseline in Heart Rate
Week 40 pre-dose - baseline
Measured: Baseline to Week 40 pre-dose
Change From Baseline in PR Interval
Measured: Baseline to Week 40 pre-dose
Change From Baseline in QRS Interval
Week 40 pre-dose - baseline
Measured: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval
Week 40 pre-dose - baseline
Measured: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Bazett)
Week 40 pre-dose - baseline
Measured: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Fridericia)
Week 40 pre-dose - baseline
Measured: Baseline to Week 40 pre-dose
Change From Baseline in Heart Rate
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in Supraventricular Premature Beat (SVPB) Total
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in SVPB Run Events
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in SVPB Pairs
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Total
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Run Events
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in VPB Pairs
Week 40 - baseline
Measured: Baseline to Week 40
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Haemoglobin
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Red Blood Cell Count
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in White Blood Cell Count
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Platelets
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils (Absolute)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils (Absolute)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils (Absolute)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes (Absolute)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes (Absolute)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Calcium
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Phosphate
Week 48 - baseline
Measured: 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)
Week 48 - baseline
Measured: 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)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Alkaline Phosphatase
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lactic Dehyrogenase (LDH)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Glucose
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Urea
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Blood Urea Nitrogen
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Creatinine
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Bilirubin, Total
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Uric Acid
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Protein, Total
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Albumin
Week 48 - baseline
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.
Measured: Weeks 2, 8, 16, 24, 32, 40, 48
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.
Measured: Weeks 2, 8, 16, 24, 32, 40, 48
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.
Measured: Weeks 2, 8, 16, 24, 32, 40, 48
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
Measured: Week 48
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.
Measured: Week 48
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.
Measured: Week 48
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.
Measured: Week 48
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.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168831
- Sponsor's protocol ID
- 205.255
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2005
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 32943047Hohlfeld 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.
PubMed 25496316Hodder 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.
PubMed 21814460
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00168831
- Acronym / sponsor ID
- 205.255
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Jun 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 7 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium Respimat 5mcg (Tio R5) | Other | Drug: Tiotropium Inhalation Solution |
| Tiotropium Respimat 10mcg (Tio R10) | Other | Drug: Tiotropium Inhalation Solution |
| Placebo | Other | Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium Inhalation Solution | Drug | Tiotropium Respimat 10mcg (Tio R10), Tiotropium Respimat 5mcg (Tio R5) |
| Placebo | Other | Placebo |
Primary outcome
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
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.
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.
54 secondary outcomes
Change From Baseline in Heart Rate
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in PR Interval
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QRS Interval
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Bazett)
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Fridericia)
Time frame: Baseline to Week 40 pre-dose
Change From Baseline in Heart Rate
Time frame: Baseline to Week 40
Change From Baseline in Supraventricular Premature Beat (SVPB) Total
Time frame: Baseline to Week 40
Change From Baseline in SVPB Run Events
Time frame: Baseline to Week 40
Change From Baseline in SVPB Pairs
Time frame: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Total
Time frame: Baseline to Week 40
Change From Baseline in Ventricular Premature Beat (VPB) Run Events
Time frame: Baseline to Week 40
Change From Baseline in VPB Pairs
Time frame: Baseline to Week 40
Change From Baseline in Haematocrit, Packed Cell Volume (PCV)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Haemoglobin
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Red Blood Cell Count
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in White Blood Cell Count
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Platelets
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Neutrophils (Absolute)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Eosinophils (Absolute)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Basophils (Absolute)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lymphocytes (Absolute)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Monocytes (Absolute)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Calcium
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Phosphate
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Alkaline Phosphatase
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Lactic Dehyrogenase (LDH)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Glucose
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Urea
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Blood Urea Nitrogen
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Creatinine
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Bilirubin, Total
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Uric Acid
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32943047Singh 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.
- Derived from this study: PubMed 25496316Hohlfeld 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.
- Derived from this study: PubMed 21814460Hodder 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
76 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium Inhalation Solution in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 76 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Italy, Austria, France, Netherlands and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168831, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.