AsthmaPhase 2NCT00116103
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
A Phase 2 study testing Tacrolimus Inhalation Aerosol in people with Asthma, run by Astellas Pharma Inc at 21 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tacrolimus Inhalation Aerosol
- How many people
- Not given
- Where
- 21 sitesUnited States
- Study dates
- Jun 2005to Apr 2006
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of persistent asthma for at least 6 months
- Require use of beta-agonists at least four times per week
Who cannot join
- Diagnosis of chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Boise, Idaho, 83704
Study site
Cincinnati, Ohio, 45241
Study site
Daytona Beach, Florida, 32114
Study site
Denver, Colorado, 80206
Study site
Encinitas, California, 92024
Study site
Los Angeles, California, 90025
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33176
Study site
Milwaukee, Wisconsin, 53209
Study site
Missoula, Montana, 59804
Study site
Oklahoma City, Oklahoma, 73120
Study site
Omaha, Nebraska, 68131
Study site
Providence, Rhode Island, 02906
Study site
River Forest, Illinois, 60305
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92120
Study site
San Jose, California, 95128
Study site
Scottsdale, Arizona, 85251
Study site
South Bend, Indiana, 46617
Study site
Spartanburg, South Carolina, 29303
Study site
St Louis, Missouri, 63141
About this study
Official title: A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.
Read the detailed description
The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.
- Conditions
- Asthma
- Being tested
- Tacrolimus Inhalation Aerosol
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Inhalation AerosolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in FEV1 from baseline to end-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2005 (estimated)
- Study startJun 2005
- Study completionApr 2006
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
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- Astellas Medical Monitor, MD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116103
- Sponsor's protocol ID
- 04-0-213
- Status last verified
- Jun 2012
- First submitted
- 27 Jun 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma
- ClinicalTrials.gov ID
- NCT00116103
- Acronym / sponsor ID
- 04-0-213
- Conditions
- Asthma
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jun 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 28 Jun 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 effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.
Detailed description
The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of persistent asthma for at least 6 months
- Require use of beta-agonists at least four times per week
Key exclusion criteria (1 listed)
- Diagnosis of chronic obstructive pulmonary disease (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 |
|---|---|---|
| Tacrolimus Inhalation Aerosol | Drug | – |
Primary outcome
The primary outcome is the change in FEV1 from baseline to end-treatment.
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 7 Jun 2012.
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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.
Astellas Medical Monitor, MD study director
Astellas Pharma US, Inc.
21 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 Tacrolimus Inhalation Aerosol in people with Asthma, run by Astellas Pharma Inc at 21 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 1 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The primary outcome is the change in FEV1 from baseline to end-treatment.. 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 7 Jun 2012.