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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)

NCT ID: NCT00242320

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Keywords

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COPD chronic obstructive pulmonary disease Roflumilast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Roflumilast 500 µg

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo

2

Placebo

Group Type PLACEBO_COMPARATOR

Roflumilast

Intervention Type DRUG

to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo

Placebo

Intervention Type DRUG

Interventions

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Roflumilast

to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

Hong Kong, , Hong Kong

Site Status

Altana Pharma/Nycomed

Shatin, NT, Hong Kong, , Hong Kong

Site Status

Altana Pharma/Nycomed

Jalan Rasah, Seremban, , Malaysia

Site Status

Altana Pharma/Nycomed

Kota Bharu / Kelantan, , Malaysia

Site Status

Altana Pharma/Nycomed

Kota Kinabalu, Sabah, , Malaysia

Site Status

Altana Pharma/Nycomed

Kuala Lumpur, , Malaysia

Site Status

Altana Pharma/Nycomed

Kuala Lumpur, , Malaysia

Site Status

Altana Pharma/Nycomed

Kuala Lumpur, , Malaysia

Site Status

Altana Pharma/Nycomed

Manila, , Philippines

Site Status

Altana Pharma/Nycomed

Quezon City, , Philippines

Site Status

Altana Pharma/Nycomed

Quezon City, , Philippines

Site Status

Altana Pharma/Nycomed

Quezon City, , Philippines

Site Status

Altana Pharma/Nycomed

Quezon City, , Philippines

Site Status

Altana Pharma/Nycomed

Anvang-Si, Gveonggi-Do, , South Korea

Site Status

Altana Pharma/Nycomed

Gangwon-do, , South Korea

Site Status

Altana Pharma/Nycomed

Gangwon-Do, , South Korea

Site Status

Altana Pharma/Nycomed

Gwangju, , South Korea

Site Status

Altana Pharma/Nycomed

Gyeonggi-do, , South Korea

Site Status

Altana Pharma/Nycomed

Jiniu-Si. Gveongsangnam-Do, , South Korea

Site Status

Altana Pharma/Nycomed

Jungbuk, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Uijongbu-city, Gveonggi-Do, , South Korea

Site Status

Altana Pharma/Nycomed

Ulsan, , South Korea

Site Status

Altana Pharma/Nycomed

Kaohsiung City, , Taiwan

Site Status

Altana Pharma/Nycomed

Taipei, , Taiwan

Site Status

Altana Pharma/Nycomed

Taipei, , Taiwan

Site Status

Altana Pharma/Nycomed

Tau-Yuan, , Taiwan

Site Status

Countries

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Hong Kong Malaysia Philippines South Korea Taiwan

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4480&filename=BY217-M2-119-RDS-2008-07-09.pdf

BY217-M2-119-RDS-2008-07-09.pdf

Other Identifiers

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BY217/M2-119

Identifier Type: -

Identifier Source: org_study_id