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Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Study NCT00669617   Information provided by Novartis
First Received: April 28, 2008   Last Updated: September 1, 2008   History of Changes

April 28, 2008
September 1, 2008
April 2008
August 2008   (final data collection date for primary outcome measure)
Forced expiratory volume in 1 second (FEV1) at 5 mins post dose of indacaterol (150 and/or 300 μg) as compared to placebo
Same as current
Complete list of historical versions of study NCT00669617 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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

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

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Chronic Obstructive Pulmonary Disease
  • Drug: Indacaterol 150 µg
  • Drug: Indacaterol 300 µg
  • Drug: Salmeterol/fluticasone (50/500 μg)
  • Drug: Salbutamol 200 µg
  • Drug: Placebo
  • Experimental: Indacaterol 150 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
  • Experimental: Indacaterol 300 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
  • Active Comparator: Salmeterol/fluticasone (50/500 μg) fixed-dose combination delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
  • Active Comparator: Salbutamol 200 μg delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
  • Placebo Comparator: Placebo delivered via matching devices
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
75
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Hungary
 
NCT00669617
External Affairs, Novartis
CQAB149B2307, EUDRACT: 2007-006189-14
Novartis
 
 
Novartis
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP