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Post Marketing Surveillance of Roflumilast in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02068456
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Drug: Roflumilast

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.

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Study Type : Observational
Actual Enrollment : 1837 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of Roflumilast in Korea
Actual Study Start Date : September 18, 2012
Actual Primary Completion Date : April 26, 2017
Actual Study Completion Date : April 26, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Group/Cohort Intervention/treatment
Roflumilast
Roflumilast will be administered according to the prescribing information of the approved Korean label.
Drug: Roflumilast
Other Name: Daxas, Daliresp




Primary Outcome Measures :
  1. Number of participants with adverse events and adverse drug reactions [ Time Frame: 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.


Secondary Outcome Measures :
  1. Effectiveness of treatment [ Time Frame: Baseline to at least 1 month after administration of Roflumilast ]

    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.

  2. Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to at least 1 month after administration of Roflumilast ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients prescribed roflumilast in the Republic of Korea.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068456


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02068456    
Other Study ID Numbers: RO-2455-402-KR
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by AstraZeneca:
Drug therapy
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases