Pulmonary Disease, Chronic ObstructivePhase 3NCT00274547
Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 26 sites in United States.
Trial summary
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period. 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
- 1,829 participants
- Where
- 26 sitesUnited States
- Study dates
- Sep 2001to Feb 2003
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Respiratory Diseases (111A)
Bay Pines, Florida
Boehringer Ingelheim Investigational Site
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Boston, Massachusetts
Boehringer Ingelheim Investigational Site
Buffalo, New York
Dallas VAMC
Dallas, Texas
Boehringer Ingelheim Investigational Site
Durham, North Carolina
J. Hillis Miller Health Center
Gainesville, Florida
Hampton VA Medical Center
Hampton, Virginia
Veteran Affairs Medical Center
Hines, Illinois
Veterans Affairs Medical Center
Houston, Texas
Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
Boehringer Ingelheim Investigational Site
Kansas City, Missouri
Boehringer Ingelheim Investigational Site
Lexington, Kentucky
VA Long Beach Healthcare System
Long Beach, California
4720 I-10 Service Road
Metairie, Louisiana
Veteran Affairs Medical Center
Minneapolis, Minnesota
Bronx VA Medical Center
New York, New York
Veterans Affairs Medical Center
North Chicago, Illinois
Boehringer Ingelheim Investigational Site
Omaha, Nebraska
Boehringer Ingelheim Investigational Site
Palo Alto, California
Carl T. Hayden VA Medical Center
Phoenix, Arizona
Boehringer Ingelheim Investigational Site
Reno, Nevada
Hunter Holmes McGuire Medical Center
Richmond, Virginia
Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
Boehringer Ingelheim Investigational Site
San Antonio, Texas
Southern Arizona VA Health Care System
Tuscon, Arizona
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
- 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.
Percentage of patients experiencing an exacerbation
Measured: 6 months
Percentage of patients hospitalized for a COPD exacerbation
Measured: 6 months
Secondary outcomes (9)
Time to first COPD exacerbation
Measured: 6 months
Time to first hospitalization associated with an COPD exacerbation
Measured: 6 months
Total number of days of corticosteroids for an COPD exacerbation
Measured: 6 months
Total number of antibiotics for an COPD exacerbation
Measured: 6 months
Number of unscheduled out-patient visits
Measured: 6 months
Total number of hospital admissions and total hospital days
Measured: 6 months
Trough post-dose FEV1 and FVC
Measured: after 3 and 6 months
90 minute post-dose FEV1 and FVC
Measured: after 3 and 6 months
Occurrence of serious adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startSep 2001
- Primary completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,829 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
- NCT00274547
- Sponsor's protocol ID
- 205.266
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
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
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
- ClinicalTrials.gov ID
- NCT00274547
- Acronym / sponsor ID
- 205.266
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,829 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Feb 2003 (actual)
- First posted
- 11 Jan 2006 (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 primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
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
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
Percentage of patients experiencing an exacerbation
Time frame: 6 months
Percentage of patients hospitalized for a COPD exacerbation
Time frame: 6 months
9 secondary outcomes
Time to first COPD exacerbation
Time frame: 6 months
Time to first hospitalization associated with an COPD exacerbation
Time frame: 6 months
Total number of days of corticosteroids for an COPD exacerbation
Time frame: 6 months
Total number of antibiotics for an COPD exacerbation
Time frame: 6 months
Number of unscheduled out-patient visits
Time frame: 6 months
Total number of hospital admissions and total hospital days
Time frame: 6 months
Trough post-dose FEV1 and FVC
Time frame: after 3 and 6 months
90 minute post-dose FEV1 and FVC
Time frame: after 3 and 6 months
Occurrence of serious adverse events
Time frame: 6 months
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.
- 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
26 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 26 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?
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 26 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?
Percentage of patients experiencing an exacerbation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.