Tacrolimus in Asthma, Bronchial and Bronchial Asthma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: tacrolimus

Study Type

Interventional

Enrollment (Actual)

370

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Pleven, Bulgaria, 5800
  - Rousse, Bulgaria, 7000
  - Sofia, Bulgaria, 1431
  - Varna, Bulgaria, 9010
Czech Republic
- - Brno, Czech Republic, 656 91
  - Krhanice, Czech Republic, 257 42
  - Olomouc, Czech Republic, 775 20
  - Sumperk, Czech Republic, 787 52
Germany
- - Berlin, Germany, 10969
  - Berlin, Germany, 12203
  - Berlin, Germany, 13597
  - Berlin, Germany, 10717
  - Berlin, Germany, 14050
  - Berlin, Germany, 10365
  - Berlin, Germany, 13357
  - Berlin, Germany, 12687
  - Bonn, Germany, 53119
  - Deggendorf, Germany, 94469
  - Dusseldorf, Germany, 40217
  - Hannover, Germany, 30159
  - Munchen, Germany, 80802
  - Potsdam, Germany, 14469
  - Rudersdorf, Germany, 15562
  - Solingen, Germany, 42651
  - Wiesbaden, Germany, 65187
Hungary
- - Budapest, Hungary, 1125
  - Csorna, Hungary, 9300
  - Fuzesabony, Hungary, 3390
  - Nyiregyhaza, Hungary, 4400
  - Szombathely, Hungary, 9700
Poland
- - Bialystok, Poland, 15-025
  - Krakow, Poland, 31-133
  - Lodz, Poland, 90-153
  - Lodz, Poland, 91-520
  - Lublin, Poland, 20-718
  - Tarnow, Poland, 33-100
  - Wroclaw, Poland, 50-434
Russian Federation
- - Ekaterinburg, Russian Federation, 620142
  - Moscow, Russian Federation, 143420
  - Moscow, Russian Federation, 107066
  - Rostov-na-Donu, Russian Federation, 344015
  - Smolensk, Russian Federation, 214018
  - St. Petersburg, Russian Federation, 197022
  - St. Petersburg, Russian Federation, 194354
  - St. Petersburg, Russian Federation, 194291
  - St. Petersburg, Russian Federation, 197291
Ukraine
- - Dnepropetrovsk, Ukraine, 49044
  - Donetsk, Ukraine, 83003
  - Kiev, Ukraine, 03680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

Study Director: R.G.M.vom Amsterdam, MD, Astellas Pharma Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria