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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.
First Received: April 28, 2008   Last Updated: November 30, 2009   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00669617
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol 150 µg
Drug: Indacaterol 300 µg
Drug: Salmeterol/fluticasone (50/500 μg)
Drug: Salbutamol 200 µg
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 75
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Indacaterol 150 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol 150 µg
2: Experimental
Indacaterol 300 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol 300 µg
3: Active Comparator
Salmeterol/fluticasone (50/500 μg) fixed-dose combination delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
Drug: Salmeterol/fluticasone (50/500 μg)
4: Active Comparator
Salbutamol 200 μg delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
Drug: Salbutamol 200 µg
5: Placebo Comparator
Placebo delivered via matching devices
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669617

Locations
United States, Florida
Novartis Investigative Site
Tamarac, Florida, United States, 33321
United States, Louisiana
Novartis Investigator Site
Lafayette, Louisiana, United States, 70503
United States, Missouri
Novartis Investigative Site
St Charles, Missouri, United States, 63301-2847
United States, North Carolina
Novartis Investigative site
Shelby, North Carolina, United States, 28150
United States, Pennsylvania
Novartis Investigative Site
Beaver, Pennsylvania, United States, 15009
Belgium
Novartis Investigative Site
Antwerpen, Belgium
Germany
Novartis Investigative site
Hamburg, Germany
Novartis Investigative site
Hannover, Germany
Novartis Investigative site
Dortmund, Germany
Novartis Investigative site
Wiesbaden, Germany
Novartis Investigative site
Mainz, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigator Site
Potsdam, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigator Site
Borstel, Germany
Hungary
Novartis Investigative site
Debrecen, Hungary
Novartis Investigative site
Deszk, Hungary
Novartis Investigative Site
Nyiregyhaza, Hungary
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CQAB149B2307, EUDRACT: 2007-006189-14
Study First Received: April 28, 2008
Last Updated: November 30, 2009
ClinicalTrials.gov Identifier: NCT00669617     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Hungary: National Institute of Pharmacy;   United States: Food and Drug Administration

Keywords provided by Novartis:
chronic obstructive pulmonary disease
COPD
indacaterol
adults

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Albuterol
Reproductive Control Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010