Strategy to Improve Adherence of Roflumilast

Phase 4UnknownNCT02018432

Asan Medical Center80 enrolled

Overview

Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache, diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued treatment around for two weeks according to experiences of clinicians. These adverse events occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of patients at the early stage of treatments. Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast 500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and then escalating dose of 500 μg once daily).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

This is a randomized, prospective, open label, comparative study to assess whether the administration of roflumilast by dose escalation varies the incidence of discontinuations due to adverse events when compared with the usual dosage in severe and very severe COPD patients. Roflumilast 250 μg once daily for 4 weeks and then increased dose of Roflumilast 500 μg once daily for 12 weeks

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female older than 40 years 2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory volume in 1 s \[FEV1\]/forced vital capacity \[FVC\] ratio ≤70%) at least 4 weeks prior to the study and post-bronchodilator FEV1 is 50% or less than the predicted value 3. Former smokers or current smokers with at least a 10 pack-year history 4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians, specialists or allied healthcare professionals, or emergency room, or hospitalization due to purulent sputum or increased sputum, or increased dyspnea) in the previous year (at least one) 5. Chronic bronchitis (cough and sputum production for at least three months within two years) 6. Able to have the signed written informed consent prior to any study-related procedures. Exclusion Criteria: 1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit 2. Known a1-antitrypsin deficiency 3. Need for long-term oxygen therapy 4. Moderate to severe liver impairment (Child-Pugh B or C) 5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc) 6. Severe acute infectious diseases 7. Cancers 8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term) except short-term systemic corticosteroids) 9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster 10. Subjects with congestive heart failure (NYHA grades 3 and 4) 11. Subjects with a history of depression associated with suicidal ideation or behavior 12. Clinically meaningful bronchiectasis 13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception 14. Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients 15. Patients with previous Roflumilast therapy within past 3 months

Locations (1)

Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

medication(Roflumilas) history taking

In every follow-up, patients will be asked about their medication history. The patients will count the rest of the Roflumilast that they are going to take in the future.

Time frame: 16 weeks

Secondary Outcomes

Laboratory test : Hematology, Biochemistry, and Urinalysis

•Laboratory test : Hematology, Biochemistry, and Urinalysis

Time frame: 16 weeks

Urine pregnancy test

•Urine pregnancy test

Time frame: 16 weeks

Chest X-ray Test

•Chest X-ray Test

Time frame: 16 weeks

ECG Test

•ECG Test

Time frame: 16 weeks

Lung Function Test

•Lung Function Test

Time frame: 16 weeks

QoL Questionnaire (CAT score)

•QoL Questionnaire (CAT score)

Time frame: 16 weeks

Other tests (HBsAg, HCV, HIV)

•Other tests (HBsAg, HCV, HIV)

Time frame: 16 weeks

Strategy to Improve Adherence of Roflumilast

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts