Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Indacaterol 150 µg (Drug); Indacaterol 300 µg (Drug); Salmeterol/fluticasone (50/500 μg) (Drug); Salbutamol 200 µg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Overall contact:
Novartis, Phone: 41-61-324-1111
Summary
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to
salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Triple-Dummy, Placebo Controlled, Multicenter, 5-Period, Single-Dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Forced expiratory volume in 1 second (FEV1) at 5 mins post dose of indacaterol (150 and/or 300 μg) as compared to placebo
Secondary outcome: FEV1 at 5 mins post dose of indacaterol (150 and 300 μg) versus salmeterol/fluticasone (50/500 μg)FEV1 at 5 mins post dose of indacaterol (150 and 300 μg) versus salbutamol (200 μg) FEV1 at 5 mins post dose of salmeterol/fluticasone (50/500 μg) and salbutamol (200 μg) versus placebo
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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 COPD (moderate-to-severe as classified by the GOLD
Guidelines, 2006) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/FVC < 70%, where FVC is forced vital capacity ('Post-' refers
to 15-30 mins 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 15h 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
Locations and Contacts
Novartis, Phone: 41-61-324-1111
Novartis Investigative site, Hamburg, Germany; Recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Hannover, Germany; Recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Dortmund, Germany; Recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Wlesband, Germany; Recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Mainz, Germany; Recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Debrecen, Hungary; Not yet recruiting
Phone: 41-61-324-1111
Novartis Investigative site, Deszk, Hungary; Not yet recruiting
Phone: 41-61-324-1111
Novartis Investigative Site, Nyiregyhaza, Hungary; Not yet recruiting
Phone: 41-61-324-1111
Additional Information
Starting date: April 2008
Ending date: September 2008
Last updated: April 29, 2008
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