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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
551
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
mean change from randomization to endpoint in lung function (post bronchodilator)
Time frame: 12 weeks
mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters
Time frame: 12 weeks
exacerbation rate
Time frame: 12 weeks
adverse events
Time frame: 12 weeks
changes in laboratory values
Time frame: 12 weeks
changes in vital signs
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Altana Pharma/Nycomed
Hong Kong, Hong Kong
Altana Pharma/Nycomed
Shatin, NT, Hong Kong, Hong Kong
Altana Pharma/Nycomed
Jalan Rasah, Seremban, Malaysia
Altana Pharma/Nycomed
Kota Bharu / Kelantan, Malaysia
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, Malaysia
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia
Altana Pharma/Nycomed
Manila, Philippines
Altana Pharma/Nycomed
Quezon City, Philippines
...and 22 more locations