Pulmonary Disease, Chronic ObstructivePhase 3NCT00239460
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 12 sites in United States.
Trial summary
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring 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
- How many people
- 196 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2003to Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
- Smoking history greater than or equal to 10 pack years
- Not history of clinical diagnosis of asthma and/or atopy
- A history of thoracotomy with pulmonary resection
- Patients requiring the use of supplemental oxygen therapy for >12 hours per day
- Chronic use of systemic corticosteroids in an unstable daily dose
- Patients with a recent history of myocardial infarction
- A known hypersensitivity to anticholinergic drugs
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pulmonary and Critical Care Services, PC
Albany, New York
Respiratory Diseases (111A)
Bay Pines, Florida
Attn: William C. Bailey, M.D.
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
The Oregon Clinic
Portland, Oregon
LSU Health Sciences Center
Shreveport, Louisiana
Olive View UCLA Medical Center
Sylmar, California
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado
About this study
Official title: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium
- 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.
TiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (12)
Trough FEV1 at Visit 3
Measured: week 8
Trough FVC at Visits 3 and 4
Measured: week 8 and week 12
FEV1 and FVC 90 min post study drug inhalation at all visits
Measured: 90 minutes post-medication
Use of rescue medication
Measured: 12 weeks
Patient's Global Evaluation
Measured: week 8 and week 12
Physician's Global Evaluation
Measured: week 8 and week 12
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
Measured: week 8 and week 12
Adverse events
Measured: 12 weeks
Vital signs
Measured: week 8 and week 12
Physical Exam
Measured: week 12
12-lead ECG
Measured: week 8 and week 12
24-hour holter ECG monitoring
Measured: week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJul 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 196 participants
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
- NCT00239460
- Sponsor's protocol ID
- 205.284
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2005
- Last updated
- 1 Nov 2013
- Results posted
- No
Publications
Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
PubMed 25496316
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
- ClinicalTrials.gov ID
- NCT00239460
- Acronym / sponsor ID
- 205.284
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
- Smoking history greater than or equal to 10 pack years
- Not history of clinical diagnosis of asthma and/or atopy
- A history of thoracotomy with pulmonary resection
- Patients requiring the use of supplemental oxygen therapy for >12 hours per day
Key exclusion criteria (0 listed)
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 | Drug | – |
Primary outcome
Trough FEV1 after 12 weeks of treatment
Time frame: 12 weeks
12 secondary outcomes
Trough FEV1 at Visit 3
Time frame: week 8
Trough FVC at Visits 3 and 4
Time frame: week 8 and week 12
FEV1 and FVC 90 min post study drug inhalation at all visits
Time frame: 90 minutes post-medication
Use of rescue medication
Time frame: 12 weeks
Patient's Global Evaluation
Time frame: week 8 and week 12
Physician's Global Evaluation
Time frame: week 8 and week 12
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
Time frame: week 8 and week 12
Adverse events
Time frame: 12 weeks
Vital signs
Time frame: week 8 and week 12
Physical Exam
Time frame: week 12
12-lead ECG
Time frame: week 8 and week 12
24-hour holter ECG monitoring
Time frame: week 8 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- 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.
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trough FEV1 after 12 weeks of treatment (time frame: 12 weeks). 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 NCT00239460, which also lists 1 linked publication.
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 1 Nov 2013.