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
- -
Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients
- Conditions
- Interventions
- First Posted Date
- 2020-12-08
- Last Posted Date
- 2022-04-21
- Lead Sponsor
- Maastricht University Medical Center
- Target Recruit Count
- 81
- Registration Number
- NCT04658654
- Locations
- 🇳🇱
University of Maastricht, Faculty of Psychology and Neuropsychology, Maastricht, Netherlands
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
- Conditions
- Interventions
- First Posted Date
- 2020-11-19
- Last Posted Date
- 2024-04-18
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Target Recruit Count
- 3980
- Registration Number
- NCT04636814
- Locations
- 🇧🇬
Chiesi Clinical Trial - Site 100527, Lovech, Bulgaria
🇧🇬Chiesi Clinical Trial - Site 100533, Kozloduy, Bulgaria
🇺🇸Chiesi Clinical Trial - Site 840724, Muncie, Indiana, United States
Efficacy of Roflumilast in the Treatment of Psoriasis
- First Posted Date
- 2020-09-16
- Last Posted Date
- 2023-06-28
- Lead Sponsor
- Bispebjerg Hospital
- Target Recruit Count
- 46
- Registration Number
- NCT04549870
- Locations
- 🇩🇰
Bispebjerg Hospital, Copenhagen, Denmark
Roflumilast TMS-EEG Plasticity
- Conditions
- Interventions
- First Posted Date
- 2020-04-30
- Last Posted Date
- 2021-12-28
- Lead Sponsor
- University of Calgary
- Registration Number
- NCT04369547
- Locations
- 🇨🇦
University of Calgary, Calgary, Alberta, Canada
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
- Conditions
- Interventions
- First Posted Date
- 2019-10-10
- Last Posted Date
- 2019-10-10
- Lead Sponsor
- Prince of Songkla University
- Target Recruit Count
- 40
- Registration Number
- NCT04122547
- Locations
- 🇹🇭
Songklanagarind hospital, Songkhla, Thailand
Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
- First Posted Date
- 2019-09-30
- Last Posted Date
- 2023-10-24
- Lead Sponsor
- University of California, Davis
- Target Recruit Count
- 5
- Registration Number
- NCT04108377
- Locations
- 🇺🇸
UC Davis, Sacramento, California, United States
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
- First Posted Date
- 2019-09-16
- Last Posted Date
- 2019-10-03
- Lead Sponsor
- Assiut University
- Target Recruit Count
- 35
- Registration Number
- NCT04090294
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
- Conditions
- Interventions
- First Posted Date
- 2019-08-28
- Last Posted Date
- 2024-06-10
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 1250
- Registration Number
- NCT04069312
- Locations
- 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States
🇺🇸Mount Sinai, New York, New York, United States
🇺🇸Lenox Hill Hospital/Northwell Health, New York, New York, United States
Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis
- First Posted Date
- 2019-06-17
- Last Posted Date
- 2020-01-13
- Lead Sponsor
- University of Sao Paulo General Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT03988816
- Locations
- 🇧🇷
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
- First Posted Date
- 2018-12-05
- Last Posted Date
- 2022-09-02
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- Target Recruit Count
- 332
- Registration Number
- NCT03764475
- Locations
- 🇨🇦
Arcutis Clinical Site 11, Surrey, British Columbia, Canada
🇨🇦Arcutis Clinical Site 25, London, Ontario, Canada
🇺🇸Arcutis Clinical Site 35, Beverly Hills, California, United States
Drug Development Updates
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