Strategy to Improve Adherence of Roflumilast

NCT02018432 | Unknown Phase 4 DMC

• 1 other identifier: Roflumilast_compliance
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (7)

• Laboratory test : Hematology, Biochemistry, and Urinalysis

  16 weeks

• Urine pregnancy test

  16 weeks

• Chest X-ray Test

  16 weeks

• ECG Test

  16 weeks

• Lung Function Test

  16 weeks

Study Arms (2)

Roflumilast escalation dosage

EXPERIMENTAL

Roflumilast 250 μg qd (4 weeks) →500 μg qd

Drug: Roflumilast escalation dosage

Roflumilast conventional dosage

EXPERIMENTAL

Roflumilast 500 μg qd

Drug: Roflumilast conventional dosage

Interventions

Roflumilast escalation dosage DRUG

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

Also known as: Daxas

Roflumilast escalation dosage

Roflumilast conventional dosage DRUG

Roflumilast 500 μg once daily for 12 weeks

Also known as: Daxas

Roflumilast conventional dosage

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female older than 40 years
• 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
• Former smokers or current smokers with at least a 10 pack-year history
• 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)
• Chronic bronchitis (cough and sputum production for at least three months within two years)
• Able to have the signed written informed consent prior to any study-related procedures.

You may not qualify if:

• COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
• Known a1-antitrypsin deficiency
• Need for long-term oxygen therapy
• Moderate to severe liver impairment (Child-Pugh B or C)
• Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc)
• Severe acute infectious diseases
• Cancers
• 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)
• Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster
• Subjects with congestive heart failure (NYHA grades 3 and 4)
• Subjects with a history of depression associated with suicidal ideation or behavior
• Clinically meaningful bronchiectasis
• Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception
• Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients
• Patients with previous Roflumilast therapy within past 3 months

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (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, 138-736, South Korea

Location

Related Publications (1)

• Park TS, Kang J, Lee JS, Oh YM, Lee SD, Lee SW. Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Apr 16;14:871-879. doi: 10.2147/COPD.S191033. eCollection 2019.

  PMID: 31354255 DERIVED

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

• Sei Won Lee, MD

  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, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sei Won Lee, MD

CONTACT

+82-2-3010-3990; iseiwon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

KR (1)