Clinical trial NCT00558285 (phase 2, status: completed)
Conditions: chronic obstructive pulmonary disease (copd)
ICD codes: G91.1, I42.1, N11.1, J05.0, G47.33, J44.9, N13.8
Drugs: indacaterol/glycopyrrolate, indacaterol, glycopyrrolate, placebo
SMILES: C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1, C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Consented male or female adults aged ≥40 years

          -  Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to
             the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)

          -  Patients who have smoking history of at least 10 pack years

          -  Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30%
             and <80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity
             (FVC) <0.70 at Visit 1 and Visit 3

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for
             chronic hypoxemia, or who have been hospitalized or visited an emergency room for a
             COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening
             period

          -  Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at
             screening

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             confirms no longer active) or clinically significant bronchiectasis

          -  Any history of asthma

          -  Patients who have clinically relevant lab abnormalities / conditions such as (but not
             limited to) long term prednisone therapy, unstable ischemic heart disease, left
             ventricular failure, history of myocardial infarction, arrhythmia (excluding stable
             atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma,
             symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe
             renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic
             state or any condition which might compromise patient safety or compliance, interfere
             with evaluation, or preclude completion of the study

          -  Patients with a history of cardiac failure, life threatening arrhythmias (screening
             Holter) and acute ischemic changes (screening ECG)

          -  Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval
             measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)

          -  History of malignancy of any organ system, treated or untreated within the past 5
             years

          -  Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or
             Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1

        Other protocol-defined inclusion/exclusion criteria may apply