Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)

October 31, 2016 updated by: AstraZeneca

A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2
  • 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

  • Japan
      • Osaka, Japan
        • Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Main inclusion criteria:

  • Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
  • No change in asthma treatment during the last 4 weeks prior to the registration
  • Non-smokers or ex-smokers for 12 months or more
  • %FEV1 ranging between 60 and 80%

Main exclusion criteria:

  • Patients with poorly controlled asthma
  • Inhalation therapy exceeding low dose during 4 weeks prior to the registration
  • Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation

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
change in lung function parameters.

Secondary Outcome Measures

Outcome Measure
pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Mitsubishi Tanabe Pharma Corporation

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

May 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APTA-2217-05

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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