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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00242320
First received: October 19, 2005
Last updated: May 4, 2012
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
COPD
Drug: Roflumilast
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • mean change from randomization to endpoint in lung function (post bronchodilator) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • exacerbation rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • changes in laboratory values [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • changes in vital signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 551
Study Start Date: August 2005
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Roflumilast 500 µg
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
Placebo Comparator: 2
Placebo
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242320

Locations
Hong Kong
Altana Pharma/Nycomed
Hong Kong, Hong Kong, 852
Altana Pharma/Nycomed
Shatin, NT, Hong Kong, Hong Kong
Korea, Republic of
Altana Pharma/Nycomed
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, 140-757
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 158-710
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 138-736
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 137-701
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 136-705
Altana Pharma/Nycomed
Uijongbu-city, Gveonggi-Do, Korea, Republic of, 480-130
Altana Pharma/Nycomed
Ulsan, Korea, Republic of, 682-060
Malaysia
Altana Pharma/Nycomed
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, 59100
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50590
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 56000
Philippines
Altana Pharma/Nycomed
Manila, Philippines, 1000
Altana Pharma/Nycomed
Quezon City, Philippines, 870
Altana Pharma/Nycomed
Quezon City, Philippines, 1102
Altana Pharma/Nycomed
Quezon City, Philippines, 850
Altana Pharma/Nycomed
Quezon City, Philippines, 1100
Taiwan
Altana Pharma/Nycomed
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
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Sang-Do Lee, Prof. University of Ulsan, College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00242320     History of Changes
Other Study ID Numbers: BY217/M2-119
Study First Received: October 19, 2005
Last Updated: May 4, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by Takeda:
COPD
chronic obstructive pulmonary disease
Roflumilast

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014