Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Inclusion criteria

• Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
• Patients diagnosed with COPD at 40 years of age or older.
• Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
• Patients with stable COPD in Patient Group B according to GOLD 2014.

Exclusion criteria

• Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
• Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
• Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
• Patients with a history of asthma.