Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: indacaterol/glycopyrrolate; indacaterol; glycopyrrolate; placebo
Intervention description: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.; Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.; Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.; Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 257.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Indacaterol; QVA149

Summary:

      An investigational inhalation product (QVA149) for the treatment of patients with Chronic
      Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate
      the effect on heart rate and cardiovascular effects to ensure the product is safe.
    

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