Post Marketing Surveillance of Roflumilast in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,837
- 主要终点
- Number of participants with adverse events and adverse drug reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signed the 'Informed Consent Form' prior to use-result surveillance enrollment.
- •Has severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of exacerbations.
- •Plans to take Roflumilast as add on to bronchodilator treatment.
- •Has not participated in the study before.
排除标准
- •Is hypersensitive to the principal components and additives of this product .
- •Suffers from moderate or severe liver diseases (Child-Pugh Class B or C).
- •Suffers from severe immune system disorders (e.g., human immunodeficiency virus (HIV) infection, multiple sclerosis, systemic lupus erythematosus, progressive multifocal leukoencephalopathy etc.).
- •Suffers from severe acute infectious diseases.
- •Suffers from cancer(excluding basal cell carcinoma).
- •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.
- •Suffers from latent infections (e.g., tuberculosis, viral hepatitis, herpes virus infections, herpes zoster and etc.).
- •Suffers from congestive heart failure (New York Heart Association (NYHA) Class III or IV).
- •Has a history of depression with suicidal thoughts or behaviors.
- •Has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this drug contains lactose.
研究组 & 干预措施
Roflumilast
Roflumilast will be administered according to the prescribing information of the approved Korean label.
干预措施: Roflumilast (Drug)
结局指标
主要结局
Number of participants with adverse events and adverse drug reactions
时间窗: Baseline to at least 1 month after administration of Roflumilast .
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. An Adverse Drug Reaction (ADR) is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in humans. A serious AE or ADR is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
次要结局
- Effectiveness of treatment(Baseline to at least 1 month after administration of Roflumilast)
- Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)(Baseline to at least 1 month after administration of Roflumilast)