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

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ClinicalTrials.gov Identifier: NCT00189722
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 17, 2008
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by:
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date April 17, 2008
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00189722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma, Bronchial
  • Bronchial Asthma
Intervention  ICMJE Drug: Tacrolimus
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April¬†15,¬†2008)
160
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Poland,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189722
Other Study ID Numbers  ICMJE FG-506-17-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Astellas Pharma Europe B.V.
Investigators  ICMJE
Study Director: R. G. M. vom Amsterdam, MD Astellas Pharma Europe B.V.
PRS Account Astellas Pharma Inc
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP