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Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

Primary Purpose

Asthma, Bronchial, Bronchial Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma, Bronchial focused on measuring Tacrolimus, Immunosuppressant, Anti-asthmatic drug, Administration, inhalation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of asthma Patients treated with inhaled corticosteroid and long acting beta 2 agonist FEV1(forced expiratory volume in 1 second)>50% to 80% Exclusion Criteria: Respiratory infection within 2weeks Asthma exacerbation within 6 weeks

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 15, 2008
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00189722
Brief Title
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial, Bronchial Asthma
Keywords
Tacrolimus, Immunosuppressant, Anti-asthmatic drug, Administration, inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tacrolimus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of asthma Patients treated with inhaled corticosteroid and long acting beta 2 agonist FEV1(forced expiratory volume in 1 second)>50% to 80% Exclusion Criteria: Respiratory infection within 2weeks Asthma exacerbation within 6 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. G. M. vom Amsterdam, MD
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
City
Krhanice
ZIP/Postal Code
25742
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Sumperk
ZIP/Postal Code
78752
Country
Czech Republic
City
Berlin
ZIP/Postal Code
10365
Country
Germany
City
Berlin
ZIP/Postal Code
10717
Country
Germany
City
Berlin
ZIP/Postal Code
14050
Country
Germany
City
Deggendort
ZIP/Postal Code
94469
Country
Germany
City
Hamburg
ZIP/Postal Code
20535
Country
Germany
City
Hannover
ZIP/Postal Code
30159
Country
Germany
City
Munchen
ZIP/Postal Code
80802
Country
Germany
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
City
Bialystok
ZIP/Postal Code
15-025
Country
Poland
City
Krakow
ZIP/Postal Code
31-133
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-434
Country
Poland
City
Ekaterinburg
ZIP/Postal Code
620142
Country
Russian Federation
City
Moscow
ZIP/Postal Code
143420
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197291
Country
Russian Federation
City
Dnepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
City
Zaporozhye
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

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