Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Post Marketing Surveillance of Roflumilast in Korea
Verified date | June 2017 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
Status | Completed |
Enrollment | 1837 |
Est. completion date | April 26, 2017 |
Est. primary completion date | April 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events and adverse drug reactions | 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. | Baseline to at least 1 month after administration of Roflumilast . | |
Secondary | Effectiveness of treatment | After at least 1 month of administration of Roflumilast the Investigator will classify the effectiveness of treatment relative to Baseline taking into account the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2010 Guidelines using the following classification: Improvement: if the symptom is deemed to take a turn for a better No Change: if no particular changes are shown compared to before administration Worsening: the symptom is worsened compared to before administration Un-assessable: the symptom is not able to be evaluated. |
Baseline to at least 1 month after administration of Roflumilast | |
Secondary | Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation and is measured by spirometry. | Baseline to at least 1 month after administration of Roflumilast |
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