Pulmonary Disease, Chronic Obstructive  >>  Daliresp (roflumilast)  >>  Phase 3
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13 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Daliresp (roflumilast) / AstraZeneca
OPUS, NCT00076089: Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

Completed
3
1100
US, Canada, Europe, RoW
Roflumilast
AstraZeneca
Chronic Obstructive Pulmonary Disease, COPD
12/05
12/05
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

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)

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)

Completed
3
933
Canada, Europe, RoW
Roflumilast, Placebo
AstraZeneca
Chronic Obstructive Pulmonary Disease (COPD)
07/07
02/08
HELIOS, NCT00424268 / 2006-004508-37: Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The Study (BY217/M2-128)

Completed
3
743
Europe
Roflumilast, Placebo
AstraZeneca
Chronic Obstructive Pulmonary Disease
01/08
07/08
HERMES, NCT00297115 / 2005-003938-18: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The Study (BY217/M2-125)

Completed
3
1568
Europe, Canada, US, RoW
Roflumilast, Placebo
AstraZeneca
Chronic Obstructive Pulmonary Disease (COPD)
04/08
08/08
AURA, NCT00297102 / 2005-003937-42: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The Study (BY217/M2-124)

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:

Completed
3
626
RoW
Roflumilast, Placebo, Salbutamol
AstraZeneca
COPD
05/12
05/12
OPTIMIZE, NCT02165826 / 2013-001788-21: Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD

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
HERO, NCT00108823 / 2004-000288-89: The -study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

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)

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)

Completed
3
1100
Canada, Europe, RoW
Roflumilast
AstraZeneca
Chronic Obstructive Pulmonary Disease, COPD
 
 
NCT00242294: Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

Completed
2/3
570
Japan
Roflumilast
AstraZeneca, Mitsubishi Tanabe Pharma Corporation
Chronic Obstructive Pulmonary Disease (COPD)
09/06
03/07

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