Efficacy and Safety of Glycopyrronium/Formoterol Fumarate fixed-dose combination relative to Umeclidinium/Vilanterol fixed-dose combination over 24 Weeks in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease - AERISTO

Exclusion Criteria

• - Respiratory disease other than COPD, including:
• - Current diagnosis of asthma
• - Alpha-1 Antitrypsin Deficiency as the cause of COPD
• - Other respiratory disorders and conditions as listed in the protocol
• - Severe COPD exacerbation (resulting in hospitalisation) not resolved within 8 weeks prior to screening, or moderate exacerbation not resolved within 4 weeks, or during screening
• - Pneumonia or lower respiratory tract infection that required antibiotics within 8 weeks prior to screening, or during screening.
• - Significant diseases or conditions other than COPD which may put the patient at risk, or influence the results of the study or the patient's ability to participate, including cardiac disease, advanced renal disease, and cancer that has not been in complete remission for at least 5 years.
• - Patients who have needed additions or alterations to their usual maintenance therapy for COPD due to worsening symptoms within 1 month prior to and during screening
• - Treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids within 4 weeks, prior to screening. (Patients maintained on an equivalent of 5 mg prednisone per day for at least 3 months prior to screening are allowed.)