Roflumilast
- Generic Name
- Roflumilast
- Brand Names
- Daliresp, Zoryve, Daxas
- Drug Type
- Small Molecule
- Chemical Formula
- C17H14Cl2F2N2O3
- CAS Number
- 162401-32-3
- Unique Ingredient Identifier
- 0P6C6ZOP5U
- Background
Roflumilast is a highly selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is a major cyclic-3',5′-adenosinemonophosphate (cyclic AMP, cAMP)-metabolizing enzyme expressed on nearly all immune and pro-inflammatory cells, in addition to structural cells like those of the smooth muscle or epithelium. The resultant increase in intracellular cAMP induced by ro...
- Indication
Oral roflumilast is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Topical roflumilast is indicated to treat plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
- Associated Conditions
- Exacerbation of COPD, Psoriasis Vulgaris (Plaque Psoriasis)
- Associated Therapies
- -
Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma
- First Posted Date
- 2018-03-08
- Last Posted Date
- 2024-02-21
- Target Recruit Count
- 14
- Registration Number
- NCT03458546
- Locations
- 🇺🇸
Mays Cancer Center, UT Health San Antonio, San Antonio, Texas, United States
Long-term Observational Study of the Safety of Roflumilast
- First Posted Date
- 2017-12-22
- Last Posted Date
- 2023-09-26
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 135856
- Registration Number
- NCT03381573
- Locations
- 🇸🇪
Research Site, Solna, Sweden
The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
- Conditions
- Interventions
- First Posted Date
- 2017-03-08
- Last Posted Date
- 2017-07-27
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 12
- Registration Number
- NCT03073798
Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO
- Conditions
- First Posted Date
- 2016-07-18
- Last Posted Date
- 2016-09-13
- Lead Sponsor
- Millennium Magnetic Technologies, LLC
- Target Recruit Count
- 150
- Registration Number
- NCT02835716
- Locations
- 🇺🇸
Millennium Magnetic Technologies, LLC, Westport, Connecticut, United States
A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
- Conditions
- Interventions
- First Posted Date
- 2016-02-02
- Last Posted Date
- 2019-05-21
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Target Recruit Count
- 55
- Registration Number
- NCT02671942
- Locations
- 🇨🇳
First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
- Conditions
- Interventions
- First Posted Date
- 2015-05-22
- Last Posted Date
- 2018-03-21
- Lead Sponsor
- FLUIDDA nv
- Target Recruit Count
- 13
- Registration Number
- NCT02451540
- Locations
- 🇧🇪
University Hospital of Antwerp, Edegem, Antwerp, Belgium
Enhancement of Corticosteroid Efficacy in COPD
- First Posted Date
- 2015-01-16
- Last Posted Date
- 2018-06-19
- Lead Sponsor
- UConn Health
- Target Recruit Count
- 13
- Registration Number
- NCT02340520
- Locations
- 🇺🇸
UConnHealth, Farmington, Connecticut, United States
PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
- First Posted Date
- 2014-07-10
- Last Posted Date
- 2014-07-10
- Lead Sponsor
- University Medical Centre Ljubljana
- Target Recruit Count
- 45
- Registration Number
- NCT02187250
- Locations
- 🇸🇮
University Medical Center Ljubljana, Ljubljana, Slovenia
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
- Conditions
- Interventions
- First Posted Date
- 2014-06-18
- Last Posted Date
- 2017-04-20
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1323
- Registration Number
- NCT02165826
Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD
- First Posted Date
- 2014-03-27
- Last Posted Date
- 2017-11-24
- Lead Sponsor
- University of Miami
- Target Recruit Count
- 11
- Registration Number
- NCT02097992
- Locations
- 🇺🇸
University of Miami Divison of Pulmonary and Critical Care Medicine, Miami, Florida, United States
Drug Development Updates
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