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
- -
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
- Conditions
- Interventions
- First Posted Date
- 2006-02-28
- Last Posted Date
- 2017-01-16
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1523
- Registration Number
- NCT00297102
- Locations
- 🇬🇧
Altana Pharma/Nycomed Investigational Site, Vale of Glamorgan, United Kingdom
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
- Conditions
- Interventions
- First Posted Date
- 2006-02-28
- Last Posted Date
- 2016-11-06
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1568
- Registration Number
- NCT00297115
- Locations
- 🇪🇸
Altana Pharma/Nycomed Investigational Site, Valencia, Spain
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
- Conditions
- First Posted Date
- 2005-11-01
- Last Posted Date
- 2016-12-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 150
- Registration Number
- NCT00246922
- Locations
- 🇯🇵
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation, Osaka, Japan
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
- Conditions
- First Posted Date
- 2005-11-01
- Last Posted Date
- 2016-10-26
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 150
- Registration Number
- NCT00246935
- Locations
- 🇯🇵
Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation, Osaka, Japan
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
- Conditions
- First Posted Date
- 2005-10-20
- Last Posted Date
- 2016-11-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 450
- Registration Number
- NCT00242307
- Locations
- 🇯🇵
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation, Osaka, Japan
Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)
- First Posted Date
- 2005-10-20
- Last Posted Date
- 2016-12-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 551
- Registration Number
- NCT00242320
- Locations
- 🇨🇳
Altana Pharma/Nycomed, Tau-Yuan, Taiwan
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
- Conditions
- First Posted Date
- 2005-10-20
- Last Posted Date
- 2016-10-26
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 570
- Registration Number
- NCT00242294
- Locations
- 🇯🇵
Nycomed Japan and Mitsubishi Tanabe Oharma Corporation, Osaka, Japan
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
- Conditions
- First Posted Date
- 2005-09-14
- Last Posted Date
- 2016-12-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 2054
- Registration Number
- NCT00163527
- Locations
- 🇬🇧
ALTANA Pharma, Cities in the United Kindom, United Kingdom
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
- Conditions
- First Posted Date
- 2005-09-14
- Last Posted Date
- 2016-10-25
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 511
- Registration Number
- NCT00163475
- Locations
- 🇪🇸
ALTANA Pharma, Cities in Spain, Spain
The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)
- Conditions
- First Posted Date
- 2005-04-20
- Last Posted Date
- 2016-10-26
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 550
- Registration Number
- NCT00108823
- Locations
- 🇬🇧
ALTANA Pharma, Cities in the United Kingdom, United Kingdom
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.