Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Roflumilast 500 µg |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean change from randomization to endpoint in lung function (post bronchodilator) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters | 12 weeks | |
| exacerbation rate | 12 weeks | |
| adverse events |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Hong Kong | 852 | Hong Kong | |||
| Altana Pharma/Nycomed |
Not provided
| Label | URL |
|---|---|
| BY217-M2-119-RDS-2008-07-09.pdf | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| 12 weeks |
| changes in laboratory values | 12 weeks |
| changes in vital signs | 12 weeks |
| Shatin, NT, Hong Kong |
| Hong Kong |
| Altana Pharma/Nycomed | Jalan Rasah, Seremban | 70300 | Malaysia |
| Altana Pharma/Nycomed | Kota Bharu / Kelantan | 16150 | Malaysia |
| Altana Pharma/Nycomed | Kota Kinabalu, Sabah | 88586 | Malaysia |
| Altana Pharma/Nycomed | Kuala Lumpur | 50590 | Malaysia |
| Altana Pharma/Nycomed | Kuala Lumpur | 56000 | Malaysia |
| Altana Pharma/Nycomed | Kuala Lumpur | 59100 | Malaysia |
| Altana Pharma/Nycomed | Manila | 1000 | Philippines |
| Altana Pharma/Nycomed | Quezon City | 1100 | Philippines |
| Altana Pharma/Nycomed | Quezon City | 1102 | Philippines |
| Altana Pharma/Nycomed | Quezon City | 850 | Philippines |
| Altana Pharma/Nycomed | Quezon City | 870 | Philippines |
| Altana Pharma/Nycomed | Anvang-Si, Gveonggi-Do | 431-070 | South Korea |
| Altana Pharma/Nycomed | Gangwon-do | 220-701 | South Korea |
| Altana Pharma/Nycomed | Gangwon-Do | 220-711 | South Korea |
| Altana Pharma/Nycomed | Gwangju | 501-757 | South Korea |
| Altana Pharma/Nycomed | Gyeonggi-do | 420-767 | South Korea |
| Altana Pharma/Nycomed | Jiniu-Si. Gveongsangnam-Do | 660-702 | South Korea |
| Altana Pharma/Nycomed | Seoul | 135-720 | South Korea |
| Altana Pharma/Nycomed | Seoul | 136-705 | South Korea |
| Altana Pharma/Nycomed | Seoul | 137-701 | South Korea |
| Altana Pharma/Nycomed | Seoul | 138-736 | South Korea |
| Altana Pharma/Nycomed | Seoul | 140-757 | South Korea |
| Altana Pharma/Nycomed | Seoul | 158-710 | South Korea |
| Altana Pharma/Nycomed | Taebuk | 361-711 | South Korea |
| Altana Pharma/Nycomed | Uijongbu-city, Gveonggi-Do | 480-130 | South Korea |
| Altana Pharma/Nycomed | Ulsan | 682-060 | South Korea |
| Altana Pharma/Nycomed | Kaohsiung City | 886-807 | Taiwan |
| Altana Pharma/Nycomed | Taipei | 886-114 | Taiwan |
| Altana Pharma/Nycomed | Taipei | Taiwan |
| Altana Pharma/Nycomed | Tau-Yuan | 886-333 | Taiwan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C424423 | Roflumilast |
Not provided
Not provided
Not provided