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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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

Key facts

Study ID

NCT00669617

Run by

Novartis

People needed

89

Starts

2008-04-01

Expected to finish

2008-08-01

Last updated by the study team

2011-09-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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• Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis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

Where it is running

• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigator Site — Lafayette, Louisiana, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative site — Shelby, North Carolina, United States
• Novartis Investigative Site — Beaver, Pennsylvania, United States
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigator Site — Borstel, Germany
• Novartis Investigative site — Dortmund, Germany
• Novartis Investigative site — Hamburg, Germany
• Novartis Investigative site — Hanover, Germany
• Novartis Investigative site — Mainz, Germany
• Novartis Investigator Site — Potsdam, Germany
• Novartis Investigative site — Wiesbaden, Germany
• Novartis Investigative site — Debrecen, Hungary
• Novartis Investigative site — Deszk, Hungary
• Novartis Investigative Site — Nyíregyháza, Hungary

Full record on ClinicalTrials.gov

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