Post Marketing Surveillance of Roflumilast in Korea

NCT ID: NCT02068456

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1837 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-18
• Study Completion Date: 2017-04-26

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.

Detailed Description

The drug being tested in this study is called roflumilast. Roflumilast is used to treat people who have severe chronic obstructive pulmonary disease (COPD) forced expiratory volume in 1 second (FEV1) post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of worsening symptoms. This study will look at side effects and the lung function of people who take roflumilast.

The study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial will be conducted in Korea.. The administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, Subjects will be evaluated during routine appointments with their healthcare provider.

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 1 month. Participants will be evaluated during routine appointments with their healthcare provider.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Roflumilast

Roflumilast will be administered according to the prescribing information of the approved Korean label.

Roflumilast

Intervention Type: DRUG

Interventions

Roflumilast

Intervention Type: DRUG

Other Intervention Names

Daxas, Daliresp

Eligibility Criteria

Inclusion Criteria

• 1. Has signed the 'Informed Consent Form' prior to use-result surveillance enrollment.

2. Has severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of exacerbations.

3. Plans to take Roflumilast as add on to bronchodilator treatment. 4. Has not participated in the study before.

Exclusion Criteria

• 1. Is hypersensitive to the principal components and additives of this product .

2. Suffers from moderate or severe liver diseases (Child-Pugh Class B or C). 3. Suffers from severe immune system disorders (e.g., human immunodeficiency virus (HIV) infection, multiple sclerosis, systemic lupus erythematosus, progressive multifocal leukoencephalopathy etc.).

4. Suffers from severe acute infectious diseases. 5. Suffers from cancer(excluding basal cell carcinoma). 6. Is administered immunosuppressants (e.g.: Methotrexate, Azathioprine, Infliximab, Etanercept or long-term use of oral Corticosteroids); however short-term use of systemic corticosteroids is excluded.

7. Suffers from latent infections (e.g., tuberculosis, viral hepatitis, herpes virus infections, herpes zoster and etc.).

8. Suffers from congestive heart failure (New York Heart Association (NYHA) Class III or IV).

9. Has a history of depression with suicidal thoughts or behaviors. 10. Has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this drug contains lactose.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RO-2455-402-KR

Identifier Type: -

Identifier Source: org_study_id