Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02165826 | Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD | PHASE3 | COMPLETED | 1,323 | — | — | May 1, 2014 | Sep 1, 2015 | Apr 20, 2017 | 2 | Slovakia |
| NCT00313209 | Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) | PHASE3 | COMPLETED | 933 | — | — | Apr 1, 2006 | Feb 1, 2008 | Dec 14, 2016 | 134 | Austria, Belgium +8 |
| NCT00297115 | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125) | PHASE3 | COMPLETED | 1,568 | — | — | Mar 1, 2006 | Aug 1, 2008 | Nov 7, 2016 | 287 | United States, Canada +6 |
| NCT00297102 | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124) | PHASE3 | COMPLETED | 1,523 | — | — | Feb 1, 2006 | Sep 1, 2008 | Jan 16, 2017 | 179 | United States, Australia +9 |
| NCT00246935 | Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08) | PHASE3 | COMPLETED | 150 | — | — | May 1, 2005 | Oct 1, 2007 | Oct 26, 2016 | 1 | Japan |
| NCT00242294 | Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06) | PHASE2 | COMPLETED | 570 | — | — | Nov 1, 2004 | Mar 1, 2007 | Oct 26, 2016 | 1 | Japan |
The primary endpoint is the percentage of participants prematurely discontinuing study treatment for any reason during the Main Period from Visit 1 (V1) to Last Visit (Vend). Discontinuation is defined as permanently stopping randomized treatment; participants who resume randomized treatment after an interval will not be counted as having discontinued. The analysis used discontinuations occurring during the Main Period, irrespective of whether a participant subsequently entered into the Down-Titration Period.
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
| Arm | Type | Description |
|---|---|---|
| Roflumilast 500 μg once daily | EXPERIMENTAL | Roflumilast 500 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks. |
| Roflumilast 500 μg every other day | EXPERIMENTAL | Roflumilast 500 μg, tablets, orally, every other day, and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks. |
| Roflumilast 250 μg once daily | EXPERIMENTAL | Roflumilast 250 μg, tablets, orally, once daily for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks. |
| Roflumilast | ACTIVE_COMPARATOR | Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled |
| Placebo | PLACEBO_COMPARATOR | Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled |
| Name | Type | Description |
|---|---|---|
| Roflumilast | DRUG | Roflumilast tablets |
| Roflumilast Placebo | DRUG | Roflumilast placebo-matching tablets |
| Standard of Care COPD Treatment | DRUG | The participant is on standard of care COPD maintenance treatment including LABAs, long-acting anticholinergics, or any combination thereof taken on a constant daily dose within 12 weeks prior to Screening (Visit V0) Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics: Tiotropium, Aclidinium. |
| Placebo | DRUG | once daily |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...