NCT00189787

Brief Summary

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for phase_2

Geographic Reach
7 countries

49 active sites

Status
completed

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

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

First QC Date

September 12, 2005

Last Update Submit

April 15, 2008

Conditions

Asthma, BronchialBronchial Asthma

Keywords

TacrolimusImmunosuppressantAnti-asthmatic drugAdministration, inhalation

Interventions

tacrolimusDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma
  • Patients treated with inhaled corticosteroid
  • FEV1 (forced expiratory volume in 1 second)\>60% to 80%

You may not qualify if:

  • Respiratory infection within 2 weeks
  • Asthma exacerbation within 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

Unknown Facility

Pleven, 5800, Bulgaria

Location

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Rousse, 7000, Bulgaria

Location

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Sofia, 1431, Bulgaria

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Varna, 9010, Bulgaria

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Brno, 656 91, Czechia

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Krhanice, 257 42, Czechia

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Olomouc, 775 20, Czechia

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Šumperk, 787 52, Czechia

Location

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Berlin, 10365, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12203, Germany

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Berlin, 12687, Germany

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Berlin, 13357, Germany

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Berlin, 13597, Germany

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Berlin, 14050, Germany

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Bonn, 53119, Germany

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Deggendorf, 94469, Germany

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Düsseldorf, 40217, Germany

Location

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Hanover, 30159, Germany

Location

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München, 80802, Germany

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Potsdam, 14469, Germany

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Rüdersdorf, 15562, Germany

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Solingen, 42651, Germany

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Wiesbaden, 65187, Germany

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Budapest, 1125, Hungary

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Csorna, 9300, Hungary

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Füzesabony, 3390, Hungary

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Nyíregyháza, 4400, Hungary

Location

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Szombathely, 9700, Hungary

Location

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Bialystok, 15-025, Poland

Location

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Krakow, 31-133, Poland

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Lodz, 90-153, Poland

Location

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Lodz, 91-520, Poland

Location

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Lublin, 20-718, Poland

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Tarnów, 33-100, Poland

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Wroclaw, 50-434, Poland

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Moscow, 107066, Russia

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Moscow, 143420, Russia

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Rostov-on-Don, 344015, Russia

Location

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197291, Russia

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Smolensk, 214018, Russia

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Yekaterinburg, 620142, Russia

Location

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Dnipro, 49044, Ukraine

Location

Unknown Facility

Donetsk, 83003, Ukraine

Location

Unknown Facility

Kiev, 03680, Ukraine

Location

MeSH Terms

Conditions

AsthmaRespiratory Aspiration

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • R.G.M.vom Amsterdam, MD

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

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

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

BU(4)CZ(4)HU(5)PL(7)RU(9)DE(17)UA(3)