Post Marketing Surveillance of Roflumilast in Korea

NCT02068456 | Completed

• 1 other identifier: RO-2455-402-KR
• Study Type: observational
• Target: 1,837
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Roflumilast

Roflumilast will be administered according to the prescribing information of the approved Korean label.

Drug: Roflumilast

Interventions

Roflumilast DRUG

Also known as: Daxas, Daliresp

Roflumilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients prescribed roflumilast in the Republic of Korea.

You may qualify if:

• \. 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. 4. Has not participated in the study before.

You may not qualify if:

• \. Is hypersensitive to the principal components and additives of this product .
• \. 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.).
• \. 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.
• \. 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. 10. Has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this drug contains lactose.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: September 18, 2012
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

KR (1)