| Daliresp (roflumilast) / AstraZeneca |
FLASH, NCT00076076: The Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023) |
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| Completed | 3 | 822 | US, RoW | Roflumilast | AstraZeneca | Asthma | | 06/05 | | |
2004-004442-40: 500µg roflumilast once daily in combination with 50µg salmeterol twice daily versus 50µg salmeterol twice daily alone over 52 weeks in patients with COPD. |
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| Completed | 3 | 955 | Europe, RoW | Roflumilast, Serevent Inhaler, BY217, R03AC12, Tablet, Pressurised inhalation, solution, Serevent Inhaler | ALTANA Pharma AG | COPD | | 06/05 | | |
NCT00163475: Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015) |
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| Completed | 3 | 511 | Europe, RoW | Roflumilast | AstraZeneca | Asthma | 08/05 | 08/05 | | |
NCT00163527: Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) |
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| Completed | 3 | 2054 | US, Europe, RoW | Roflumilast | AstraZeneca, Pfizer | Asthma | 11/05 | 11/05 | | |
OPUS, NCT00076089: Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111) |
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| Completed | 3 | 1100 | US, Canada, Europe, RoW | Roflumilast | AstraZeneca | Chronic Obstructive Pulmonary Disease, COPD | 12/05 | 12/05 | | |
APTA-2217-07, NCT00246922: Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) |
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| Completed | 3 | 150 | Japan | Roflumilast | AstraZeneca, Mitsubishi Tanabe Pharma Corporation | Bronchial Asthma | 01/07 | 10/07 | | |
APTA-2217-08, NCT00246935: Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease |
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| Completed | 3 | 150 | Japan | Roflumilast | AstraZeneca, Mitsubishi Tanabe Pharma Corporation | Chronic Obstructive Pulmonary Disease (COPD) | 01/07 | 10/07 | | |
NCT00242320: Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119) |
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| Completed | 3 | 551 | RoW | Roflumilast, Placebo | AstraZeneca | COPD | 05/07 | 08/07 | | |
NCT00313209 / 2005-005080-28: Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) |
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| Completed | 3 | 933 | Canada, Europe, RoW | Roflumilast, Placebo | AstraZeneca | Chronic Obstructive Pulmonary Disease (COPD) | 07/07 | 02/08 | | |
| Completed | 3 | 743 | Europe | Roflumilast, Placebo | AstraZeneca | Chronic Obstructive Pulmonary Disease | 01/08 | 07/08 | | |
| Completed | 3 | 1568 | Europe, Canada, US, RoW | Roflumilast, Placebo | AstraZeneca | Chronic Obstructive Pulmonary Disease (COPD) | 04/08 | 08/08 | | |
| Completed | 3 | 1523 | US, Europe, RoW | Roflumilast, Placebo | AstraZeneca | Chronic Obstructive Pulmonary Disease (COPD) | 07/08 | 09/08 | | |
NCT01313494: A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore: |
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| Completed | 3 | 626 | RoW | Roflumilast, Placebo, Salbutamol | AstraZeneca | COPD | 05/12 | 05/12 | | |
ChiCTR-TRC-11001304: ACROSS (A COPD trial investigating Roflumilast on safety and effectiveness in China, Hong Kong and Singapore) |
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| Completed | 3 | 636 | | ICD-10, Placebo, tablet, oral ;ICD-10, Roflumilast 500ug, oral | the First Affiliated Hospital of Guangzhou Medical Universtiy; Nycomed GmbH, Nycomed GmbH | COPD (Chronic Obstructive Pulmonary Disease) | | | | |
| Completed | 3 | 1323 | Europe | Roflumilast, Daxas, Daliresp, Libertek, Roflumilast Placebo, Standard of Care COPD Treatment | AstraZeneca | Chronic Obstructive Pulmonary Disease (COPD) | 09/15 | 09/15 | | |
NCT04122547: Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis |
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| Completed | 3 | 40 | RoW | Roflumilast, Daxas, Placebo | Prince of Songkla University | Exacerbation Copd, Bronchiectasis, Lung Function Decreased | 12/15 | 12/15 | | |
2004-001065-18: Morning versus evening administration of 500µg Roflumilast once dailyfor 6 weeks in patients with asthma. |
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| Ongoing | 3 | 60 | Europe | Roflumilast, | ALTANA Pharma AG | Asthma | | | | |
| Completed | 3 | 158 | Europe | Roflumilast, Daxas, Placebo, Placebo to Roflumilast | AstraZeneca | COPD, Chronic Obstructive Pulmonary Disease | 02/16 | 02/16 | | |
| Completed | 3 | 13 | US | Theophylline, Roflumilast | UConn Health | COPD | 08/16 | 08/16 | | |
NCT00073177: Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012) |
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| Completed | 3 | 819 | US, RoW | Roflumilast | AstraZeneca | Asthma | | | | |
| Completed | 3 | 550 | US, Canada, Europe, RoW | Roflumilast | AstraZeneca | Chronic Obstructive Pulmonary Disease, COPD | | | | |
NCT00062582: Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110) |
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| Completed | 3 | 1000 | US, Canada, RoW | Roflumilast | AstraZeneca | Chronic Obstructive Pulmonary Disease, COPD | | | | |
NCT00430729: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112) |
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| Completed | 3 | 1100 | Canada, Europe, RoW | Roflumilast | AstraZeneca | Chronic Obstructive Pulmonary Disease, COPD | | | | |
NCT01973998: Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization |
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| Completed | 3 | 68 | US | Roflumilast, Daliresp, Placebo, Inactive substance | Temple University, Forest Laboratories | COPD | 11/17 | 11/17 | | |
NCT04755946: Possible Role of Roflumilast in Diabetic Nephropathy |
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| Not yet recruiting | 3 | 48 | NA | Roflumilast, Placebo | Tanta University | Diabetic Nephropathies | 06/21 | 07/21 | | |
NCT04800172: The Possible Effects of Roflumilast on Obesity Related Disorders |
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| Completed | 3 | 66 | RoW | Roflumilast, placebo | Tanta University | Obesity, PreDiabetes | 03/22 | 03/22 | | |
NCT05369793: Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy |
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| Completed | 3 | 60 | RoW | Alpha lipoic acid, Roflumilast | Tanta University | Type 2 Diabetes (Adult Onset), Diabetic Neuropathies | 10/23 | 10/23 | | |
NCT06860958: Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
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| Recruiting | 3 | 60 | RoW | Fluoxetine, Roflumilast, Placebo | Tanta University | Depressive Disorder, Major | 03/26 | 08/26 | | |
PILLAR, NCT04636814 / 2020-003648-97: 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. |
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| Terminated | 3 | 3973 | Europe, US, RoW | CHF6001 1600µg, CHF6001 3200µg, Placebo, Roflumilast | Chiesi Farmaceutici S.p.A., Chiesi Farmaceutici S.p.A. | Chronic Obstructive Pulmonary Disease | 12/25 | 12/25 | | |
NCT00242307: Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05) |
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| Completed | 2/3 | 450 | Japan | Roflumilast | AstraZeneca, Mitsubishi Tanabe Pharma Corporation | Bronchial Asthma | 09/06 | 06/07 | | |
NCT00242294: Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06) |
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| Completed | 2/3 | 570 | Japan | Roflumilast | AstraZeneca, Mitsubishi Tanabe Pharma Corporation | Chronic Obstructive Pulmonary Disease (COPD) | 09/06 | 03/07 | | |
| Completed | 2/3 | 30 | RoW | Roflumilast, Roflumilast oral, Methotrexate, Methotrexate tablets | Cairo University | Psoriasis | 05/23 | 05/23 | | |
