The intention with the study is to have a better understanding of what happens to COPD
patients' symptoms, lung function and markers of inflammation over 12 weeks. This information
will increase the understanding of COPD and how to design new treatments for COPD in the
This is a Phase IV, open-label, single-arm, single-site study. The purpose of this
exploratory study is to gain longitudinal insights into the relationships between the
inflammatory profile, symptoms, lung function, and reliever use in subjects with chronic
obstructive pulmonary disease (COPD).
The study will include a minimum of 8 clinic visits and consist of a Screening Visit (Visit
1), a 4-week run-in period, a Baseline Visit (Visit 2) and a 12-week observational period,
including 6 visits scheduled every 2 weeks. To standardise the use of COPD medications all
subjects will receive maintenance Duaklir and reliever Ventolin for the duration of the
study. During the observational period, additional visits may occur if subjects experience a
worsening of their COPD symptoms. For each individual subject, the duration of participation
in the study will be 16 weeks.
Estimated study duration is approximately 20 months including approximately 50 patients.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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