Post Marketing Surveillance of Roflumilast in Korea

• Status: Completed
• Trial end date: 2017-04-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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.