Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

NCT ID: NCT00189787

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma, Bronchial Bronchial Asthma

Keywords

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Tacrolimus Immunosuppressant Anti-asthmatic drug Administration, inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Respiratory infection within 2 weeks
* Asthma exacerbation within 90 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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R.G.M.vom Amsterdam, MD

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Brno, , Czechia

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Krhanice, , Czechia

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Olomouc, , Czechia

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Šumperk, , Czechia

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Deggendorf, , Germany

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Düsseldorf, , Germany

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Hanover, , Germany

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München, , Germany

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Potsdam, , Germany

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Rudersdorf, , Germany

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Solingen, , Germany

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Wiesbaden, , Germany

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Budapest, , Hungary

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Csorna, , Hungary

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Füzesabony, , Hungary

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Nyíregyháza, , Hungary

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Szombathely, , Hungary

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Bialystok, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Tarnów, , Poland

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Wroclaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Yekaterinburg, , Russia

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Kiev, , Ukraine

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Countries

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Bulgaria Czechia Germany Hungary Poland Russia Ukraine

Other Identifiers

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FG-506-17-07

Identifier Type: -

Identifier Source: org_study_id