COPDPhase 3NCT00280371
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD
A Phase 3 study testing Formoterol Fumarate in people with COPD, run by Dey at 52 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
- 52 sitesUnited States
- Study dates
- Jan 2006to May 2007
- 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
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Research Site
Abingdon, Virginia, 24210
Research Site
Asheville, North Carolina, 28801
Research Site
Atlanta, Georgia, 30309
Research Site
Austin, Texas, 78750
Research Site
Buena Park, California, 90620
Research Site
Camillus, New York, 13030
Research Site
Charlotte, North Carolina, 28207
Research Site
Cincinnati, Ohio, 45231
Research Site
Cincinnati, Ohio, 45242
Research Site
Clearwater, Florida, 33765
Research Site
Coeur d'Alene, Idaho, 83814
Research Site
Costa Mesa, California, 92626
Research Site
Cranston, Rhode Island, 02920
Research Site
Dallas, Texas, 75231
Research Site
DeLand, Florida, 32720
Research Site
Denver, Colorado, 80206
Research Site
Elizabeth City, North Carolina, 27909
Research Site
Henderson, Nevada, 89014
Research Site
Hines, Illinois, 60141
Research Site
Houston, Texas, 77030
Research Site
Huntington Beach, California, 92647
Research Site
Jasper, Alabama, 35501
Research Site
Long Beach, California, 90813
Research Site
Madison, Wisconsin, 53792
Research Site
Medford, Oregon, 97504
Research Site
Miami Beach, Florida, 33140
Research Site
Milwaukee, Wisconsin, 53209
Research Site
Minneapolis, Minnesota, 55402
Research Site
Normal, Illinois, 61761
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Overland Park, Kansas, 66210
Research Site
Phoenix, Arizona, 85006-2666
Research Site
Portland, Oregon, 97213
Research Site
Raleigh, North Carolina, 27607
Research Site
Richmond, Virginia, 23225
Research Site
Rochester, Minnesota, 55905
Research Site
San Diego, California, 92120
Research Site
Shawnee Mission, Kansas, 66216
Research Site
South Burlington, Vermont, 05403
Research Site
Spartanburg, South Carolina, 29307
Research Site
St Louis, Missouri, 63122
Research Site
St Louis, Missouri, 63141
Research Site
Stockton, California, 95207
Research Site
Summit, New Jersey, 07901
Research Site
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33603
Research Site
Topeka, Kansas, 66606
Research Site
Upland, Pennsylvania, 19013
Research Site
Waco, Texas, 76712
Research Site
Walnut Creek, California, 94598
Research Site
Wheat Ridge, Colorado, 80033
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/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer 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
- COPD, Chronic Obstructive Pulmonary Disease, 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 posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT00280371
- Sponsor's protocol ID
- 201-069
- Status last verified
- Feb 2008
- First submitted
- 19 Jan 2006
- Last updated
- 11 Nov 2010
- Results posted
- No
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
- 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/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00280371
- Acronym / sponsor ID
- 201-069
- Conditions
- COPD
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, formoterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 23 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 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 11 Nov 2010.
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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.
52 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 52 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 52 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?
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.