Strategy to Improve Adherence of Roflumilast

NCT ID: NCT02018432

Last Updated: 2013-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Roflumilast escalation dosage

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

Group Type: EXPERIMENTAL

Roflumilast escalation dosage

Intervention Type: 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

Roflumilast conventional dosage

Roflumilast 500 μg qd

Group Type: EXPERIMENTAL

Roflumilast conventional dosage

Intervention Type: DRUG

Roflumilast 500 μg once daily for 12 weeks

Interventions

Roflumilast escalation dosage

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

Intervention Type: DRUG

Roflumilast conventional dosage

Roflumilast 500 μg once daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Daxas; Daxas

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sei Won Lee

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sei Won Lee, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Countries

South Korea

Central Contacts

Sei Won Lee, MD

Role: CONTACT

Phone: +82-2-3010-3990

Email: iseiwon@gmail.com

Facility Contacts

Sei Won Lee, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 31354255 (View on PubMed)

Other Identifiers

Roflumilast_compliance

Identifier Type: -

Identifier Source: org_study_id