Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

December 1, 2016 updated by: AstraZeneca

The JADE Study: A 12-week, Double-blind, Randomized Study to Investigate the Effect of 500 mcg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

551

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

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Altana Pharma/Nycomed
      • Shatin, NT, Hong Kong, Hong Kong
        • Altana Pharma/Nycomed
  • Korea, Republic of
      • Anvang-Si, Gveonggi-Do, Korea, Republic of, 431-070
        • Altana Pharma/Nycomed
      • Chungbuk, Korea, Republic of, 361-711
        • Altana Pharma/Nycomed
      • Gangwon-Do, Korea, Republic of, 220-711
        • Altana Pharma/Nycomed
      • Gangwon-do, Korea, Republic of, 220-701
        • Altana Pharma/Nycomed
      • Gwangju, Korea, Republic of, 501-757
        • Altana Pharma/Nycomed
      • Gyeonggi-do, Korea, Republic of, 420-767
        • Altana Pharma/Nycomed
      • Jiniu-Si. Gveongsangnam-Do, Korea, Republic of, 660-702
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 135-720
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 138-736
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 136-705
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 137-701
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 140-757
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 158-710
        • Altana Pharma/Nycomed
      • Uijongbu-city, Gveonggi-Do, Korea, Republic of, 480-130
        • Altana Pharma/Nycomed
      • Ulsan, Korea, Republic of, 682-060
        • Altana Pharma/Nycomed
  • Malaysia
      • Jalan Rasah, Seremban, Malaysia, 70300
        • Altana Pharma/Nycomed
      • Kota Bharu / Kelantan, Malaysia, 16150
        • Altana Pharma/Nycomed
      • Kota Kinabalu, Sabah, Malaysia, 88586
        • Altana Pharma/Nycomed
      • Kuala Lumpur, Malaysia, 50590
        • Altana Pharma/Nycomed
      • Kuala Lumpur, Malaysia, 56000
        • Altana Pharma/Nycomed
      • Kuala Lumpur, Malaysia, 59100
        • Altana Pharma/Nycomed
  • Philippines
      • Manila, Philippines, 1000
        • Altana Pharma/Nycomed
      • Quezon City, Philippines, 1100
        • Altana Pharma/Nycomed
      • Quezon City, Philippines, 1102
        • Altana Pharma/Nycomed
      • Quezon City, Philippines, 850
        • Altana Pharma/Nycomed
      • Quezon City, Philippines, 870
        • Altana Pharma/Nycomed
  • Taiwan
      • Kaohsiung, Taiwan, 886-807
        • Altana Pharma/Nycomed
      • Taipei, Taiwan
        • Altana Pharma/Nycomed
      • Taipei, Taiwan, 886-114
        • Altana Pharma/Nycomed
      • Taipei City 114, Taiwan, 886-114
        • Altana Pharma/Nycomed
      • Tau-Yuan, Taiwan, 886-333
        • Altana Pharma/Nycomed

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Written informed consent
  • Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
  • FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
  • FEV1 (post bronchodilator) 30-80% of predicted
  • Fixed airway obstruction
  • Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
  • Clinically stable COPD within 4 weeks prior to baseline visit
  • Availability of a chest x-ray

Main Exclusion Criteria:

  • COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
  • Lower respiratory tract infection
  • Diagnosis of asthma
  • Known alpha-1-antitrypsin deficiency
  • Need for long term oxygen therapy defined as longer or equal 16 hours/day
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
  • Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
  • Diagnosis or history of cancer
  • Clinically significant cardiopulmonary abnormalities
  • Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
  • Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
  • Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
  • Alcohol or drug abuse
  • Inability to follow the study procedures due to e.g., language problems, physiological disorders
  • Use of not allowed drugs
  • Suspected hypersensitivity to the study medication or rescue medication

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
Active Comparator: 1
Roflumilast 500 µg
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean change from randomization to endpoint in lung function (post bronchodilator)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 12 weeks
12 weeks
mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters
Time Frame: 12 weeks
12 weeks
exacerbation rate
Time Frame: 12 weeks
12 weeks
changes in laboratory values
Time Frame: 12 weeks
12 weeks
changes in vital signs
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

August 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 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)

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-119

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.

Clinical Trials on COPD

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe