Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Salmeterol/fluticasone (50/500 μg); Salbutamol (200 µg); Placebo to Indacaterol; Placebo to Salmeterol/fluticasone; Placebo to salbutamol
Intervention description: Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI); Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).; Placebo to indacaterol delivered via SDDPI; Placebo to salmeterol/fluticasone delivered via MDDPI; Placebo to salbutamol delivered via MDDPI
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol; adults

Summary:

      This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to
      placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
    

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