Asthma, BronchialPhase 2NCT00189722
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
A Phase 2 study testing Tacrolimus in people with Asthma, Bronchial and Bronchial Asthma, run by Astellas Pharma Inc at 28 sites in 5 countries.
Trial summary
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma, Bronchial, Bronchial Asthma
- What is being tested?
- Tacrolimus
- How many people
- 160 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Start not givento Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma
- Patients treated with inhaled corticosteroid and long acting beta 2 agonist
- FEV1(forced expiratory volume in 1 second)>50% to 80%
Who cannot join
- Respiratory infection within 2weeks
- Asthma exacerbation within 6 weeks
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
Germany9 sites
Study site
Berlin, 10365
Study site
Berlin, 10717
Study site
Berlin, 14050
Study site
Deggendort, 94469
Study site
Hamburg, 20535
Study site
Hanover, 30159
Study site
München, 80802
Study site
Rüdersdorf, 15562
Study site
Wiesbaden, 65187
Poland6 sites
Study site
Bialystok, 15-025
Study site
Krakow, 31-133
Study site
Lodz, 90-153
Study site
Lublin, 20-718
Study site
Tarnów, 33-100
Study site
Wroclaw, 50-434
Russia6 sites
Study site
Moscow, 143420
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197291
Study site
Smolensk, 214018
Study site
Yekaterinburg, 620142
Czechia4 sites
Study site
Brno, 65691
Study site
Krhanice, 25742
Study site
Olomouc, 77520
Study site
Šumperk, 78752
Ukraine3 sites
Study site
Dnipro, 49044
Study site
Kiev, 03680
Study site
Zaporizhzhya, 69035
About this study
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
- Conditions
- Asthma, Bronchial, Bronchial Asthma
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Immunosuppressant, Anti-asthmatic drug, Administration, inhalation
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies 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
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Investigators
- R. G. M. vom Amsterdam, MD, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189722
- Sponsor's protocol ID
- FG-506-17-05
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 17 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT00189722
- Acronym / sponsor ID
- FG-506-17-05
- Conditions
- Asthma, Bronchial, Bronchial Asthma
- Keywords
- Tacrolimus, Immunosuppressant, Anti-asthmatic drug, Administration, inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 19 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.
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of asthma
- Patients treated with inhaled corticosteroid and long acting beta 2 agonist
- FEV1(forced expiratory volume in 1 second)>50% to 80%
Key exclusion criteria (2 listed)
- Respiratory infection within 2weeks
- Asthma exacerbation within 6 weeks
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Apr 2008.
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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.
R. G. M. vom Amsterdam, MD study director
Astellas Pharma Europe B.V.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus in people with Asthma, Bronchial and Bronchial Asthma, run by Astellas Pharma Inc at 28 sites in 5 countries.
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 3 inclusion and 2 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 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Poland, Russia, Czechia, Ukraine. 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.
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 17 Apr 2008.