- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00246922
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
December 1, 2016 updated by: AstraZeneca
A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma
The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05.
Roflumilast will be administered orally once daily.
The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study).
The study will provide further long-term safety and efficacy data of roflumilast.
Study Overview
Study Type
Interventional
Enrollment
150
Phase
- Phase 3
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
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Osaka, Japan
- Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
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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
20 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main inclusion criteria:
- Patients with asthma disease
- Written informed consent
- Patients who completed the 24-week evaluation of study APTA-2217-05
Main exclusion criteria:
- % FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
- Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
- Serious diseases
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .
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Secondary Outcome Measures
Outcome Measure |
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Efficacy.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
Study Start
December 1, 2004
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 31, 2005
First Submitted That Met QC Criteria
October 31, 2005
First Posted (Estimate)
November 1, 2005
Study Record Updates
Last Update Posted (Estimate)
December 2, 2016
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APTA-2217-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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