Clareo Health | A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Novartis Pharmaceuticals
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC \<0.70
Patients with a post-bronchodilator FEV1 ≥30% and \<60% of the predicted normal value
Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2
Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
You may not be if
An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period
Diagnosed asthma
Patients receiving regular long term oxygen therapy (LTOT)
Ongoing / planned rehabilitation during the study period
Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons