Clinical trial NCT02068456: Post Marketing Surveillance of Roflumilast in Korea
Official title: Post Marketing Surveillance of Roflumilast in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Drug therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 1837
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients prescribed roflumilast in the Republic of Korea.

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.

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.

Primary outcomes:
measure: Number of participants with adverse events and adverse drug reactions
timeFrame: Baseline to at least 1 month after administration of Roflumilast .
Secondary outcomes:
measure: Effectiveness of treatment
timeFrame: Baseline to at least 1 month after administration of Roflumilast
measure: Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline to at least 1 month after administration of Roflumilast
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: