Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Albuterol; Fluticasone; Salmeterol Xinafoate; Xhance

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• Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis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