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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242320
• Other study ID #: BY217/M2-119
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2005
• Last updated: December 1, 2016
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
• Placebo

Locations

Country	Name	City	State
Hong Kong	Altana Pharma/Nycomed	Hong Kong
Hong Kong	Altana Pharma/Nycomed	Shatin, NT, Hong Kong
Korea, Republic of	Altana Pharma/Nycomed	Anvang-Si, Gveonggi-Do
Korea, Republic of	Altana Pharma/Nycomed	Chungbuk
Korea, Republic of	Altana Pharma/Nycomed	Gangwon-do
Korea, Republic of	Altana Pharma/Nycomed	Gangwon-Do
Korea, Republic of	Altana Pharma/Nycomed	Gwangju
Korea, Republic of	Altana Pharma/Nycomed	Gyeonggi-do
Korea, Republic of	Altana Pharma/Nycomed	Jiniu-Si. Gveongsangnam-Do
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Uijongbu-city, Gveonggi-Do
Korea, Republic of	Altana Pharma/Nycomed	Ulsan
Malaysia	Altana Pharma/Nycomed	Jalan Rasah, Seremban
Malaysia	Altana Pharma/Nycomed	Kota Bharu / Kelantan
Malaysia	Altana Pharma/Nycomed	Kota Kinabalu, Sabah
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Philippines	Altana Pharma/Nycomed	Manila
Philippines	Altana Pharma/Nycomed	Quezon City
Philippines	Altana Pharma/Nycomed	Quezon City
Philippines	Altana Pharma/Nycomed	Quezon City
Philippines	Altana Pharma/Nycomed	Quezon City
Taiwan	Altana Pharma/Nycomed	Kaohsiung
Taiwan	Altana Pharma/Nycomed	Taipei
Taiwan	Altana Pharma/Nycomed	Taipei
Taiwan	Altana Pharma/Nycomed	Taipei City 114
Taiwan	Altana Pharma/Nycomed	Tau-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Malaysia,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change from randomization to endpoint in lung function (post bronchodilator)		12 weeks	No
Secondary	mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters		12 weeks	No
Secondary	exacerbation rate		12 weeks	No
Secondary	adverse events		12 weeks	Yes
Secondary	changes in laboratory values		12 weeks	Yes
Secondary	changes in vital signs		12 weeks	Yes

External Links

•   BY217-M2-119-RDS-2008-07-09.pdf