10 completed, 3 withdrawn, 1 active not recruiting, 1 recruiting. 17 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 17 | Completed 10, Withdrawn 3, Active not recruiting 1, Recruiting 1, Terminated 1, Unknown 1 |
| Phase 2 | 5 | Completed 3, Unknown 1, Withdrawn 1 |
Follow Roflumilast: new trials by email Literature Review of Roflumilast trials Research Report on Roflumilast
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) Loncastuximab, Roflumilast, Rituximab - Diffuse Large B-cell Lymphoma | Phase 1 | Recruiting | The University of Texas Health Science Center at San Antonio | 10 | 2025-06-20 | 2026-09-29 |
| Roflumilast and TMS Motor Plasticity Roflumilast, Placebo, Intermittent theta-burst stimulation transcranial magnetic stimulation - Other Conditions of Brain | Phase 1 | Active not recruiting | University of Calgary | 20 | 2024-11-06 | 2025-07-03 |
| Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy R-Chop and Roflumilast - Lymphoma, B-Cell | Phase 1 | Withdrawn | The University of Texas Health Science Center at San Antonio | 2024-01-01 | 2024-02-29 | |
| Efficacy of Roflumilast in Prevention of Peripheral Neuropathy Roflumilast, Placebo - Peripheral Neuropathy | Phase 1 / Phase 2 | Unknown | Mansoura University | 60 | 2023-07-01 | 2023-06-01 |
| Roflumilast TMS-EEG Plasticity Transcranial Magnetic Stimulation, Roflumilast, Placebo oral tablet - Synaptic Plasticity | Phase 1 | Withdrawn | University of Calgary | 2022-01-01 | 2021-12-28 | |
| The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients Roflumilast 500Mcg Tab, Placebo - Major Depressive Disorder | Phase 1 / Phase 2 | Withdrawn | Sadat City University | 2021-02-01 | 2025-07-14 | |
| Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma Roflumilast, Placebo - Asthma | Phase 1 | Terminated | University of California, Davis | 5 | 2019-01-21 | 2023-10-24 |
| Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma Roflumilast - Lymphoma, B-Cell | Phase 1 | Completed | The University of Texas Health Science Center at San Antonio | 14 | 2018-05-21 | 2024-02-21 |
| PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram, Whole Body PET Blocked with Roflumilast - Nervous System Disease | Phase 1 / Phase 2 | Completed | National Institute of Mental Health (NIMH) | 16 | 2018-04-04 | 2020-10-19 |
| The Role of Phosphodiesterase Inhibitors in Incretin Secretion Placebo, Roflumilast/Sitagliptin, Sitagliptin - Healthy Volunteers | Phase 1 | Completed | National Institute on Aging (NIA) | 29 | 2015-02-13 | 2026-10-08 |
| Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia Roflumilast, Placebo, Second generation antipsychotic - Schizophrenia | Phase 1 | Completed | Takeda | 20 | 2014-03-01 | 2016-10-03 |
| Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults Roflumilast, Roflumilast placebo, Donepezil - Memory Impairment, Alzheimer's Disease | Phase 1 | Completed | AstraZeneca | 27 | 2014-01-01 | 2017-02-01 |
| Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals Roflumilast - Obesity | Phase 1 / Phase 2 | Completed | National Heart, Lung, and Blood Institute (NHLBI) | 24 | 2013-05-22 | 2018-09-04 |
| Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD Roflumilast Placebo, Roflumilast - COPD | Phase 1 / Phase 2 | Completed | University of Miami | 11 | 2013-02-01 | 2017-11-24 |
| Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes Roflumilast, Alogliptin, Exenatide - Type 2 Diabetes | Phase 1 | Completed | AstraZeneca | 40 | 2012-07-01 | 2017-02-01 |
| Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects Roflumilast - Chronic Obstructive Pulmonary Disease | Phase 1 | Completed | AstraZeneca | 32 | 2011-05-01 | 2016-10-26 |
| Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol Roflumilast - Healthy | Phase 1 | Completed | AstraZeneca | 27 | 2004-04-01 | 2016-12-02 |
Lymphoma, B-Cell (2) · Pulmonary Disease, Chronic Obstructive (2) · Alzheimer Disease (1) · Asthma (1) · Depressive Disorder, Major (1) · Diabetes Mellitus, Type 2 (1) · Glucose Intolerance (1) · Hyperinsulinism (1) · Lymphoma, Large B-Cell, Diffuse (1) · Memory Disorders (1) · Muscle Cramp (1) · Nervous System Diseases (1) · Obesity (1) · Peripheral Nervous System Diseases (1) · Schizophrenia (1)
AstraZeneca (4) · The University of Texas Health Science Center at San Antonio (3) · University of Calgary (2) · Mansoura University (1) · National Heart, Lung, and Blood Institute (NHLBI) (1) · National Institute of Mental Health (NIMH) (1) · National Institute on Aging (NIA) (1) · Sadat City University (1) · Takeda (1) · University of California, Davis (1) · University of Miami (1)
United States (9) · Canada (2) · United Kingdom (2) · China (1) · Egypt (1) · Germany (1)
Adolfo E Diaz Duque, MD (2) · Adam Wanner, MD (1) · Alexander McGirr, MD PhD (1) · Chee W Chia, M.D. (1) · Jay H Chung, M.D. (1) · Nicholas Kenyon, MD (1) · Ricardo Aguiar, MD (1) · Ricardo Aguiar, MD, PhD (1) · Robert B Innis, M.D. (1)