AsthmaPhase 2NCT00215410
Study in Patients With Asthma
A Phase 2 study testing Formoterol Fumarate in people with Asthma, run by Dey at 12 sites in United States.
Trial summary
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Formoterol Fumarate
- How many people
- 36 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento Oct 2005
- Phase
- Phase 2
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a history of asthma
- Written guardian approval
Who cannot join
- Current or recent asthma exacerbation, requiring hospitalization
- History of smoking
- Debilitating or systemic and/or life-threatening diseases.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Site
Englewood, Colorado, 80112
Research Site
Fort Worth, Texas, 76107
Research Site
Houston, Texas, 77054
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90806
Research Site
Medford, Oregon, 97504
Research Site
Mission Viejo, California, 92691
Research Site
Newport Beach, California, 92660
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Orange, California, 92888
Research Site
Portland, Oregon, 97213
Research Site
Vista, California, 92084
About this study
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.
- Conditions
- Asthma
- Being tested
- Formoterol Fumarate
- Keywords
- Asthma, Formoterol, Fumarate
- Medical subject headings
- Asthma
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, AE 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 completionOct 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215410
- Sponsor's protocol ID
- DL-055
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2005
- 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
- Study in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00215410
- Acronym / sponsor ID
- DL-055
- Conditions
- Asthma
- Keywords
- Asthma, Formoterol, Fumarate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2005 (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 most safe and effective dose of the investigational drug in comparison with a control drug and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with a history of asthma
- Written guardian approval
Key exclusion criteria (3 listed)
- Current or recent asthma exacerbation, requiring hospitalization
- History of smoking
- Debilitating or systemic and/or life-threatening diseases.
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, AE 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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Asthma
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formoterol Fumarate in people with Asthma, run by Dey 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 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.