Pulmonary Disease, Chronic ObstructivePhase 3NCT00168844
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 72 sites in 14 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
- 983 participants
- Where
- 72 sitesin 14 countries
- Study dates
- Jan 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
Trial locations and contacts
72 sites in 14 countries.
72 sites in 14 countries
United States12 sites
Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
Boehringer Ingelheim Investigational Site
Fredericksburg, Virginia
Boehringer Ingelheim Investigational Site
Harker Heights, Texas
Boehringer Ingelheim Investigational Site
Harrisonburg, Virginia
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Larchmont, New York
Boehringer Ingelheim Investigational Site
Los Angeles, California
Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
Boehringer Ingelheim Investigational Site
Pismo Beach, California
Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
Boehringer Ingelheim Investigational Site
San Diego, California
Canada7 sites
Boehringer Ingelheim Investigational Site
Courtice, Ontario
Boehringer Ingelheim Investigational Site
Edmonton, Alberta
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
Boehringer Ingelheim Investigational Site
Mississauga, Ontario
Boehringer Ingelheim Investigational Site
Ottawa, Ontario
Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec
Boehringer Ingelheim Investigational Site
Toronto, Ontario
Belgium6 sites
Boehringer Ingelheim Investigational Site
Antwerp
Boehringer Ingelheim Investigational Site
Brussels
Boehringer Ingelheim Investigational Site
Genk
Boehringer Ingelheim Investigational Site
Ghent
Boehringer Ingelheim Investigational Site
Liège
Boehringer Ingelheim Investigational Site
Wavre
Netherlands6 sites
Boehringer Ingelheim Investigational Site
Breda
Boehringer Ingelheim Investigational Site
Dordrecht
Boehringer Ingelheim Investigational Site
Groningen
Boehringer Ingelheim Investigational Site
Harderwijk
Boehringer Ingelheim Investigational Site
Heerlen
Boehringer Ingelheim Investigational Site
Zutphen
United Kingdom6 sites
Boehringer Ingelheim Investigational Site
Birmingham
Boehringer Ingelheim Investigational Site
Bristol
Boehringer Ingelheim Investigational Site
Nottingham
Boehringer Ingelheim Investigational Site
Sheffield
Boehringer Ingelheim Investigational Site
Swansea
Boehringer Ingelheim Investigational Site
Torquay
Australia5 sites
Boehringer Ingelheim Investigational Site
Clayton, Victoria
Boehringer Ingelheim Investigational Site
Frankston, Victoria
Boehringer Ingelheim Investigational Site
Perth, Western Australia
Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia
Boehringer Ingelheim Investigational Site
Woodville, South Australia
France5 sites
Boehringer Ingelheim Investigational Site
Angers
Boehringer Ingelheim Investigational Site
Beuvry
Boehringer Ingelheim Investigational Site
Cambrai
Boehringer Ingelheim Investigational Site
Lille
Boehringer Ingelheim Investigational Site
Metz
Germany5 sites
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Darmstadt
Boehringer Ingelheim Investigational Site
Gelnhausen
Boehringer Ingelheim Investigational Site
Kassel
Boehringer Ingelheim Investigational Site
Rüdersdorf
Greece5 sites
Boehringer Ingelheim Investigational Site
Athens
Boehringer Ingelheim Investigational Site
Heraklion
Boehringer Ingelheim Investigational Site
Larissa
Boehringer Ingelheim Investigational Site
Maroussi, Athens
Boehringer Ingelheim Investigational Site
Melissia-Athens
Spain4 sites
Boehringer Ingelheim Investigational Site
Alicante
Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canaria
Boehringer Ingelheim Investigational Site
Madrid
Boehringer Ingelheim Investigational Site
Vic (Barcelona)
Sweden4 sites
Boehringer Ingelheim Investigational Site
Motala
Boehringer Ingelheim Investigational Site
Skövde
Boehringer Ingelheim Investigational Site
Uppsala
Boehringer Ingelheim Investigational Site
Varberg
Norway3 sites
Boehringer Ingelheim Investigational Site
Ålesund
Boehringer Ingelheim Investigational Site
Oslo
Boehringer Ingelheim Investigational Site
Trondheim
Turkey (Türkiye)3 sites
Boehringer Ingelheim Investigational Site
Ankara
Boehringer Ingelheim Investigational Site
Bursa
Boehringer Ingelheim Investigational Site
Istanbul
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 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)
Trough Forced Expiratory Volume in 1 second (FEV1)
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
Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (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 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)
Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood
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 Lymphocytes (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 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 (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)
Week 48 - baseline
Measured: Baseline to Week 48 or at premature discontinuation if before Week 48
Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (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 Dehydrogenase (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 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 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.
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 startJan 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
- 983 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
- NCT00168844
- Sponsor's protocol ID
- 205.254
- 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
- NCT00168844
- Acronym / sponsor ID
- 205.254
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 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 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
Trough Forced Expiratory Volume in 1 second (FEV1)
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
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
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 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 Lymphocytes (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 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 (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)
Time frame: Baseline to Week 48 or at premature discontinuation if before Week 48
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
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 Dehydrogenase (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.
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RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
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
72 sites in 14 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 72 sites in 14 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 72 sites in United States, Canada, Belgium, Netherlands, United Kingdom and 9 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 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). 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 NCT00168844, 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.