Strategy to Improve Adherence of Roflumilast

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02018432
• Other study ID #: Roflumilast_compliance
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 12, 2013
• Last updated: December 17, 2013
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Asan Medical Center
• Contact: Sei Won Lee, MD
• Phone: +82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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
• Roflumilast conventional dosage
Roflumilast 500 µg once daily for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Laboratory test : Hematology, Biochemistry, and Urinalysis	•Laboratory test : Hematology, Biochemistry, and Urinalysis	16 weeks	Yes
Secondary	Urine pregnancy test	•Urine pregnancy test	16 weeks	Yes
Secondary	Chest X-ray Test	•Chest X-ray Test	16 weeks	Yes
Secondary	ECG Test	•ECG Test	16 weeks	Yes
Secondary	Lung Function Test	•Lung Function Test	16 weeks	Yes
Secondary	QoL Questionnaire (CAT score)	•QoL Questionnaire (CAT score)	16 weeks	Yes
Secondary	Other tests (HBsAg, HCV, HIV)	•Other tests (HBsAg, HCV, HIV)	16 weeks	Yes