Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
1 other identifier
interventional
160
5 countries
28
Brief Summary
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedApril 17, 2008
April 1, 2008
September 12, 2005
April 15, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma
- Patients treated with inhaled corticosteroid and long acting beta 2 agonist
- FEV1(forced expiratory volume in 1 second)\>50% to 80%
You may not qualify if:
- Respiratory infection within 2weeks
- Asthma exacerbation within 6 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma Europe B.V.collaborator
Study Sites (28)
Unknown Facility
Brno, 65691, Czechia
Unknown Facility
Krhanice, 25742, Czechia
Unknown Facility
Olomouc, 77520, Czechia
Unknown Facility
Šumperk, 78752, Czechia
Unknown Facility
Berlin, 10365, Germany
Unknown Facility
Berlin, 10717, Germany
Unknown Facility
Berlin, 14050, Germany
Unknown Facility
Deggendort, 94469, Germany
Unknown Facility
Hamburg, 20535, Germany
Unknown Facility
Hanover, 30159, Germany
Unknown Facility
München, 80802, Germany
Unknown Facility
Rüdersdorf, 15562, Germany
Unknown Facility
Wiesbaden, 65187, Germany
Unknown Facility
Bialystok, 15-025, Poland
Unknown Facility
Krakow, 31-133, Poland
Unknown Facility
Lodz, 90-153, Poland
Unknown Facility
Lublin, 20-718, Poland
Unknown Facility
Tarnów, 33-100, Poland
Unknown Facility
Wroclaw, 50-434, Poland
Unknown Facility
Moscow, 143420, Russia
Unknown Facility
Saint Petersburg, 194291, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197291, Russia
Unknown Facility
Smolensk, 214018, Russia
Unknown Facility
Yekaterinburg, 620142, Russia
Unknown Facility
Dnipro, 49044, Ukraine
Unknown Facility
Kiev, 03680, Ukraine
Unknown Facility
Zaporizhzhya, 69035, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
R. G. M. vom Amsterdam, MD
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
April 17, 2008
Record last verified: 2008-04