Clinical trial NCT00669617 (phase 3, status: completed)
Conditions: chronic obstructive pulmonary disease
ICD codes: J44.9, J44.1, J44.0
Drugs: indacaterol, salmeterol/fluticasone (50/500 μg), salbutamol (200 µg), placebo to indacaterol, placebo to salmeterol/fluticasone, placebo to salbutamol
SMILES: CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1, CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior
             to initiation of any study-related procedure

          -  Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
             (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:

               -  Smoking history of at least 20 pack years

               -  Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) <80% and ≥30% of
                  the predicted normal value.

               -  Post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 70%, where FVC is forced
                  vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 μg of
                  salbutamol at Visit 2)

        Exclusion Criteria:

          -  Pregnant / nursing women or women of child-bearing potential

          -  Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic
             hypoxemia

          -  Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to
             Visit 3

          -  Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3

          -  Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no
             longer active) or clinically significant bronchiectasis

          -  Any history of asthma, including: blood eosinophil count >400/mm3; onset of asthma
             symptoms prior to age 40 years

          -  History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is
             prolonged (>450ms for males or >470ms for females)

          -  Clinically relevant lab abnormalities / conditions such as (but not limited to)
             unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled
             hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic
             state or any condition which in the investigator's opinion might compromise patient
             safety or compliance, interfere with evaluation, or preclude completion of the study

          -  Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0%
             of total hemoglobin measured at Visit 2

          -  Any patient with lung cancer or any active cancer or a history of cancer with less
             than 5 years disease-free survival time

          -  History of hypersensitivity to any of the study drugs

          -  Irregular day/night, waking/sleeping cycles e.g. shift workers

          -  Live attenuated vaccinations within 30 days prior to Visit 2

          -  Investigational drug within 30 days prior to Visit 2

          -  Known history of non-compliance or not able to use devices or perform spirometry

        Other protocol-defined inclusion/exclusion criteria may apply