Status:
COMPLETED
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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
- 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
- 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- Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00669617
Start Date
April 1 2008
End Date
August 1 2008
Last Update
September 12 2011
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Tamarac, Florida, United States, 33321
2
Novartis Investigator Site
Lafayette, Louisiana, United States, 70503
3
Novartis Investigative Site
Saint Charles, Missouri, United States, 63301-2847
4
Novartis Investigative site
Shelby, North Carolina, United States, 28150