COPDPhase 3NCT00215449
Study in Patients With COPD
A Phase 3 study testing Formoterol Fumarate in people with COPD, run by Dey at 68 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Formoterol Fumarate
- How many people
- 690 participants
- Where
- 68 sitesUnited States
- Study dates
- Start not givento Apr 2006
- 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
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
Who cannot join
- Medical diagnosis of asthma
- Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
Research Site
Albuquerque, New Mexico, 87108
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78750
Research Site
Bay Pines, Florida, 33744
Research Site
Bessemer, Alabama, 35023
Research Site
Birmingham, Alabama, 35209
Research Site
Blue Ridge, Georgia, 30513
Research Site
Buena Park, California, 90620
Research Site
Butte, Montana, 59701
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Cherry Hill, New Jersey, 08003
Research Site
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45220
Research Site
Cincinnati, Ohio, 45231
Research Site
Cincinnati, Ohio, 45241
Research Site
Cincinnati, Ohio, 45245
Research Site
Clearwater, Florida, 33765
Research Site
Colorado Springs, Colorado, 80907
Research Site
Columbus, Ohio, 43215
Research Site
DeLand, Florida, 32720
Research Site
Denver, Colorado, 80206
Research Site
Easton, Pennsylvania, 18045
Research Site
Edina, Minnesota, 55438
Research Site
El Paso, Texas, 79902
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Encinitas, California, 92024
Research Site
Evansville, Indiana, 47714
Research Site
Hartford, Connecticut, 06105
Research Site
Henderson, Nevada, 89014
Research Site
Hines, Illinois, 60141
Research Site
Houston, Texas, 77024
Research Site
Houston, Texas, 77030
Research Site
Huntington Beach, California, 92647
Research Site
Larchmont, New York, 10538
Research Site
Los Angeles, California, 90048
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40215
Research Site
Madison, Wisconsin, 53792
Research Site
Medford, Oregon, 97504
Research Site
Milwaukee, Wisconsin, 53209
Research Site
Minneapolis, Minnesota, 55402
Research Site
Minneapolis, Minnesota, 55407
Research Site
Minneapolis, Minnesota, 55416
Research Site
Mission Viejo, California, 92691
Research Site
New Hyde Park, New York, 11040
Research Site
New Orleans, Louisiana, 70115
Research Site
Normal, Illinois, 61761
Research Site
Omaha, Nebraska, 68134
Research Site
Papillion, Nebraska, 68046
Research Site
Phoenix, Arizona, 85006-2666
Research Site
Portland, Oregon, 97213
Research Site
Richmond, Virginia, 23225
Research Site
Rochester, Minnesota, 55905
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92120
Research Site
Sepulveda, California, 91343
Research Site
Shawnee Mission, Kansas, 66216
Research Site
Slidell, Louisiana, 70461
Research Site
Spartanburg, South Carolina, 29307
Research Site
Springfield, New Jersey, 07081
Research Site
Stockton, California, 95207
Research Site
Tampa, Florida, 33607
Research Site
Topeka, Kansas, 66606
Research Site
Tuscon, Arizona, 85715
Research Site
Tuscon, Arizona, 85723
Research Site
Tuscon, Arizona, 85745
Research Site
Walnut Creek, California, 94598
Research Site
Waterbury, Connecticut, 06708
Research Site
Wheat Ridge, Colorado, 80033
About this study
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.
- Conditions
- COPD
- Being tested
- Formoterol Fumarate
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, formoterol, formoterol fumarate
- 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.
Formoterol FumarateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of lung function
Secondary outcomes (2)
Change in lung function, as well as vital signs
Physical Exam results, Adverse Event reporting, etc
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Primary completionDec 2005
- Study completionApr 2006
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 COPDStudies of the same condition, open and under way.
- 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
- 690 participants
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215449
- Sponsor's protocol ID
- DL-059
- Status last verified
- Jan 2009
- First submitted
- 13 Sep 2005
- Last updated
- 11 Nov 2010
- Results posted
- No
Publications
Donohue JF, Hanania NA, Fogarty C, Campbell SC, Rinehart M, Denis-Mize K. Long-term safety of nebulized formoterol: results of a twelve-month open-label clinical trial. Ther Adv Respir Dis. 2008 Aug;2(4):199-208. doi: 10.1177/1753465808093934.
PubMed 19124372
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Patients With COPD
- ClinicalTrials.gov ID
- NCT00215449
- Acronym / sponsor ID
- DL-059
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, formoterol, formoterol fumarate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Sep 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 purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.
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 (2 listed)
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
Key exclusion criteria (3 listed)
- Medical diagnosis of asthma
- Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
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 |
|---|---|---|
| Formoterol Fumarate | Drug | – |
Primary outcome
Measure of lung function
2 secondary outcomes
Change in lung function, as well as vital signs
Physical Exam results, Adverse Event reporting, etc
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 11 Nov 2010.
- Results publication: PubMed 19124372Donohue JF, Hanania NA, Fogarty C, Campbell SC, Rinehart M, Denis-Mize K. Long-term safety of nebulized formoterol: results of a twelve-month open-label clinical trial. Ther Adv Respir Dis. 2008 Aug;2(4):199-208. doi: 10.1177/1753465808093934.
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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.
The record lists no contact. Use the official record to reach the sponsor.
68 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 Formoterol Fumarate in people with COPD, run by Dey at 68 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 2 inclusion and 3 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 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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?
Measure of lung function. 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 NCT00215449, 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 11 Nov 2010.