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)
The purpose of this study was to determine whether a fixed dose combination of indacaterol
 and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic
 Obstructive Pulmonary Disease.
Inclusion Criteria:

 -  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)

 Exclusion Criteria:

 -  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

 Other protocol-defined inclusion/exclusion criteria may apply.