AsthmaPhase 2NCT00215371
Study in Patients With Asthma
A Phase 2 study testing Formoterol Fumarate in people with Asthma, run by Dey at 2 sites in United States.
Trial summary
The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Formoterol Fumarate
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Nov 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Require the regular use of an inhaled beta-2-selective adrenergic agent.
- No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.
Who cannot join
- Active acute or chronic disorders of the respiratory system within one month prior to screening.
- Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
- Debilitating systemic and/or life-threatening diseases.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Long Beach, California, 90806
Research Site
Medford, Oregon, 97504
About this study
The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
- Conditions
- Asthma
- Being tested
- Formoterol Fumarate
- Keywords
- Asthma, Pediatric, Formoterol Fumarate, Foradil
- 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.
Primary: The primary efficacy outcome is measure of lung function.
Secondary outcomes (1)
Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, 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 startJul 2002
- Primary completionOct 2002
- Study completionNov 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
- 32 participants
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215371
- Sponsor's protocol ID
- DL-050
- 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
- NCT00215371
- Acronym / sponsor ID
- DL-050
- Conditions
- Asthma
- Keywords
- Asthma, Pediatric, Formoterol Fumarate, Foradil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Nov 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 which dose of the investigational drug is safest and most effective compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Require the regular use of an inhaled beta-2-selective adrenergic agent.
- No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.
Key exclusion criteria (3 listed)
- Active acute or chronic disorders of the respiratory system within one month prior to screening.
- Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
- Debilitating 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
Primary: The primary efficacy outcome is measure of lung function.
1 secondary outcome
Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, 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.
2 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 2 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 2 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?
Primary: The primary efficacy outcome is 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.