Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent must be obtained before any assessment is performed.
Male and female ≥ 40 years
Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at visit 1
Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value and post-bronchodilator FEV1/FVC \< 0.70 at visit 1
Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to visit 1
Documented CAT score of ≥ 10 at Visit 1 and 2
You may not be if
Treatment with any LAMA in the 2 weeks prior to visit 1
Presence of any contraindication, warning, precaution, hypersensitivity in the approved prescribing information for salmeterol/fluticasone
Prior or current diagnosis of asthma
More than one COPD exacerbation requiring treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the year prior to Visit 1
Patients who developed a COPD exacerbation of any severity within the 6 weeks before the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
Respiratory tract infection within 4 weeks prior to Visit 1
Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks after resolution of the infection
Requiring oxygen therapy prescribed for \>12 hours per day
Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
