COPDPhase 3NCT00215436
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
A Phase 3 study testing Formoterol Fumarate in people with COPD, run by Dey at 44 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of the investigational drug 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
- 345 participants
- Where
- 44 sitesUnited States
- Study dates
- Mar 2005to Sep 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 diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Research Site
Albuquerque, New Mexico, 87108
Research Site
Ann Arbor, Michigan, 48106
Research Site
Buena Park, California, 90620
Research Site
Butte, Montana, 59701
Research Site
Camillus, New York, 13031
Research Site
Charlotte, North Carolina, 28207
Research Site
Cherry Hill, New Jersey, 08003
Research Site
Cincinnati, Ohio, 45241
Research Site
Clearwater, Florida, 33765
Research Site
Columbus, Ohio, 43215
Research Site
Cranston, Rhode Island, 02920
Research Site
Dallas, Texas, 75231
Research Site
DeLand, Florida, 32720
Research Site
Denver, Colorado, 80206
Research Site
Florence, Kentucky, 41042
Research Site
Hartford, Connecticut, 06105
Research Site
Henderson, Nevada, 89014
Research Site
Hines, Illinois, 60141
Research Site
Huntington Beach, California, 92647
Research Site
Jasper, Alabama, 35501
Research Site
Long Beach, California, 90806
Research Site
Long Beach, California, 90813
Research Site
Los Angeles, California, 90048
Research Site
Madison, Wisconsin, 53792
Research Site
Medford, Oregon, 97504
Research Site
Milwaukee, Wisconsin, 53209
Research Site
Minneapolis, Minnesota, 55402
Research Site
New Orleans, Louisiana, 70115
Research Site
Normal, Illinois, 61761
Research Site
Phoenix, Arizona, 85006-2666
Research Site
Portland, Oregon, 97213
Research Site
Richmond, Virginia, 23225
Research Site
Rochester, Minnesota, 55905
Research Site
Saint Charles, Missouri, 63301
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92120
Research Site
Spartanburg, South Carolina, 29307
Research Site
St Louis, Missouri, 63122
Research Site
Stockton, California, 95207
Research Site
Summit, New Jersey, 07901
Research Site
Tampa, Florida, 33603
Research Site
Tuscon, Arizona, 85715
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Woodstock, Georgia, 30189
About this study
Official title: A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
- Conditions
- COPD
- Being tested
- Formoterol Fumarate
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, formoterol
- 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)
- Study startMar 2005
- Primary completionSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 345 participants
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215436
- Sponsor's protocol ID
- 201-065
- Status last verified
- Apr 2008
- First submitted
- 13 Sep 2005
- Last updated
- 10 Nov 2010
- Results posted
- No
Publications
Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K; Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78. doi: 10.1016/j.clinthera.2007.10.007.
PubMed 18042473Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007.
PubMed 18363201
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00215436
- Acronym / sponsor ID
- 201-065
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, formoterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 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 safety and efficacy of the investigational drug 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 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 10 Nov 2010.
- Results publication: PubMed 18042473Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K; Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78. doi: 10.1016/j.clinthera.2007.10.007.
- Results publication: PubMed 18363201Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007.
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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.
44 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 44 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 10 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 44 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 NCT00215436, which also lists 2 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 10 Nov 2010.