Last Update Posted : February 17, See Contacts and Locations. Study Description. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis.
This has not previously been done. Detailed Description:. Drug Information available for: Roflumilast. FDA Resources. Arms and Interventions. Treatment according to national roflumilast guidelines. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
HIV, systemic lupus, and systemic sclerosis Current tuberculosis Current viral hepatitis Heart failure NYHA III-IV Moderate or severe liver failure Child-Pugh B-C Current or former malignancy basal cell carcinoma excluded Current or former depression with suicidal ideation Topical therapy for psoriasis during within 2 of randomization or during study Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin Confirmed pregnancy Planned pregnancy within 6 months Breast feeding Blood donation during study Inability to complete study.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. PDE4: a novel target in the treatment of chronic obstructive pulmonary disease. Clin Pharmacol Ther. After discontinuing roflumilast, patients regained one-half of their lost weight within 3 months. Notes: Bars represent confidence intervals.
Republished with permission of the Endocrine Society, from Effect of the phosphodiesterase 4 inhibitor roflumilast on glucose metabolism in patients with treatment-naive, newly diagnosed type 2 diabetes mellitus. J Clin Endocrinol Metab. Copyright ; permission conveyed through Copyright Clearance Center, Inc.
Patients diagnosed with COPD are approximately 3 and 3. Thus, the effect of COPD treatment on cardiovascular safety is a concern for both clinicians and patients. Cardiovascular safety in patients receiving roflumilast for the treatment of COPD. Treatment goals for patients with active COPD exacerbations include reducing symptoms of current exacerbations and preventing further episodes. The relationship between the development of exacerbations and disease progression and morbidity and mortality in patients with COPD underscores the importance of prevention and risk reduction.
In addition, frequent exacerbators are a distinct clinical subgroup who are at high risk and need close management. While treatment with LABAs and ICS are associated with reductions in exacerbations, patients still suffer from these episodes over time. Roflumilast is a PDE4 inhibitor with demonstrated efficacy for improving lung function and decreasing exacerbations in patients with severe to very severe COPD associated with chronic bronchitis.
This includes decreasing the incidence of exacerbations in frequent exacerbators and also of hospitalization. As of now, the benefits of roflumilast are most well established in those with severe disease. Extrapulmonary manifestations of COPD also need to be taken into consideration when managing patients. Data supporting this include the observation that roflumilast decreases the risk of cardiovascular events in patients with COPD 57 and that the drug improves glucose homeostasis in patients with type 2 diabetes mellitus.
Additional trials are underway to further define the role of roflumilast for targeting the underlying systemic inflammation associated with COPD. In summary, clinical efficacy, quality of life, and cost-effectiveness data suggest that roflumilast can be an important and cost-effective alternative to ICS in the prevention of exacerbations, particularly for patients with severe to very severe COPD associated with chronic bronchitis and a history of exacerbations. The authors report no other conflicts of interest in this work.
National Center for Biotechnology Information , U. Published online Jan 6. Author information Copyright and License information Disclaimer. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
This article has been cited by other articles in PMC. Abstract COPD is a progressive condition involving chronic inflammation and parenchymal destruction with resulting airflow limitation.
Keywords: COPD, exacerbations, phosphodiesterase-4 inhibitors, roflumilast, chronic bronchitis. Introduction COPD is a progressive condition that usually leads to a steady decline in lung function, increased symptoms, and recurrent and worsening exacerbations.
Open in a separate window. Figure 1. Schematic of the frequent exacerbator phenotype. Pharmacology Pharmacodynamics Roflumilast, a potent and selective inhibitor of phosphodiesterase-4 PDE4 , is indicated for treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Figure 2. Figure 3. Tolerability Roflumilast is generally well tolerated with adverse events AEs consistent with those expected for PDE4 inhibitors.
Figure 4. Figure 5. Place in therapy Treatment goals for patients with active COPD exacerbations include reducing symptoms of current exacerbations and preventing further episodes. References 1. Agusti AG. COPD, a multicomponent disease: implications for management. Respir Med. Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a meta-analysis.
From COPD to chronic systemic inflammatory syndrome? The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med. Saetta M. Airway inflammation in chronic obstructive pulmonary disease. Results: Among patients who underwent randomization, were assigned to roflumilast 0. The mean baseline PASI scores were 7. Application-site reactions occurred with similar frequency in the roflumilast groups and the vehicle group. Conclusions: Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks.
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