Roflumilast

Generic Name: Roflumilast

Brand Names: Daliresp, Zoryve, Daxas

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₄Cl_₂F_₂N_₂O_₃

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: -

Clinical Trials

Roflumilast and Cognition

Phase 2

Completed

Conditions: Dementia

Interventions: Drug: Placebo
Drug: roflumilast

First Posted Date: 2011-09-14

Last Posted Date: 2020-01-02

Lead Sponsor: Maastricht University Medical Center

Target Recruit Count: 22

Registration Number: NCT01433666

Locations: 🇳🇱
Maastricht University, Faculty of Psychology and Neuroscience, Maastricht, Limburg, Netherlands

A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma

Phase 2

Completed

Conditions: Allergic Asthma

Interventions: Drug: Roflumilast
Drug: Placebo

First Posted Date: 2011-06-03

Last Posted Date: 2016-10-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 48

Registration Number: NCT01365533

Locations: 🇨🇦
Nycomed investigational site, Quebec, Canada

Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

Phase 1

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Roflumilast

First Posted Date: 2011-05-17

Last Posted Date: 2016-10-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 32

Registration Number: NCT01354782

Locations: 🇨🇳
Nycomed Investigational Site, Beijing, China

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Placebo
Drug: Roflumilast

First Posted Date: 2011-04-05

Last Posted Date: 2016-12-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 1945

Registration Number: NCT01329029

Locations: 🇦🇺
Nycomed Investigational site, Daws Park, Australia
🇬🇧
Nycomed Investigational Site, Norwich, United Kingdom

A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

Phase 3

Completed

Conditions: COPD

Interventions: Drug: Roflumilast
Drug: Placebo
Drug: Salbutamol

First Posted Date: 2011-03-11

Last Posted Date: 2017-02-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 626

Registration Number: NCT01313494

Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study

Phase 2

Completed

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: Roflumilast

First Posted Date: 2010-06-09

Last Posted Date: 2016-10-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 487

Registration Number: NCT01140542

Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Roflumilast

First Posted Date: 2009-07-16

Last Posted Date: 2016-12-02

Lead Sponsor: AstraZeneca

Target Recruit Count: 27

Registration Number: NCT00940329

Locations: 🇩🇪
Nycomed, Konstanz, Germany

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease
COPD

First Posted Date: 2007-02-02

Last Posted Date: 2016-11-30

Lead Sponsor: AstraZeneca

Target Recruit Count: 1100

Registration Number: NCT00430729

Locations: 🇬🇧
ALTANA Pharma, Cities in the United Kingdom, United Kingdom

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Placebo
Drug: Roflumilast

First Posted Date: 2007-01-19

Last Posted Date: 2016-12-05

Lead Sponsor: AstraZeneca

Target Recruit Count: 743

Registration Number: NCT00424268

Locations: 🇬🇧
Altana Pharma/Nycomed Investigational Site, Yaxley, United Kingdom

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Placebo
Drug: Roflumilast

First Posted Date: 2006-04-12

Last Posted Date: 2016-12-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 933

Registration Number: NCT00313209

Locations: 🇿🇦
Altana Pharma/Nycomed Investigational Sites, Kapstadt, South Africa
🇬🇧
Altana Pharma/Nycomed Investigational Site, Watford, United Kingdom

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