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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.
First Received: October 19, 2005   Last Updated: December 12, 2008   History of Changes
Sponsored by: ALTANA Pharma
Information provided by: ALTANA Pharma
ClinicalTrials.gov Identifier: NCT00242320
  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 III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Roflumilast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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

Further study details as provided by ALTANA Pharma:

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
1: Active Comparator
Roflumilast 500 µg
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
2: Placebo Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242320

Locations
Hong Kong
Altana Pharma/Nycomed
Shatin, NT, Hong Kong, Hong Kong
Altana Pharma/Nycomed
Hong Kong, Hong Kong, 852
Korea, Republic of
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 135-720
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, 138-736
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 140-757
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 158-710
Altana Pharma/Nycomed
Jiniu-Si. Gveongsangnam-Do, Korea, Republic of, 660-702
Altana Pharma/Nycomed
Gangwon-Do, Korea, Republic of, 220-711
Altana Pharma/Nycomed
Chungbuk, Korea, Republic of, 361-711
Altana Pharma/Nycomed
Gyeonggi-do, Korea, Republic of, 420-767
Altana Pharma/Nycomed
Anvang-Si, Gveonggi-Do, Korea, Republic of, 431-070
Altana Pharma/Nycomed
Uijongbu-city, Gveonggi-Do, Korea, Republic of, 480-130
Altana Pharma/Nycomed
Gwangju, Korea, Republic of, 501-757
Altana Pharma/Nycomed
Gangwon-do, Korea, Republic of, 220-701
Altana Pharma/Nycomed
Ulsan, Korea, Republic of, 682-060
Malaysia
Altana Pharma/Nycomed
Kota Bharu / Kelantan, Malaysia, 16150
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50590
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 56000
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 59100
Altana Pharma/Nycomed
Jalan Rasah, Seremban, Malaysia, 70300
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, Malaysia, 88586
Philippines
Altana Pharma/Nycomed
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
Taiwan
Altana Pharma/Nycomed
Taipei, Taiwan
Altana Pharma/Nycomed
Kaohsiung, Taiwan, 886-807
Altana Pharma/Nycomed
Taipei City 114, Taiwan, 886-114
Altana Pharma/Nycomed
Tau-Yuan, Taiwan, 886-333
Altana Pharma/Nycomed
Taipei, Taiwan, 886-114
Sponsors and Collaborators
ALTANA Pharma
Investigators
Principal Investigator: Sang-Do Lee, Prof. University of Ulsan, College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Nycomed ( Nycomed )
Study ID Numbers: BY217/M2-119
Study First Received: October 19, 2005
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00242320     History of Changes
Health Authority: Malaysia: Ministry of Health

Keywords provided by ALTANA Pharma:
COPD
chronic obstructive pulmonary disease
Roflumilast

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

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

ClinicalTrials.gov processed this record on May 07, 2009