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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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00669617
First received: April 28, 2008
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol
Drug: Salmeterol/fluticasone (50/500 μg)
Drug: Salbutamol (200 µg)
Drug: Placebo to Indacaterol
Drug: Placebo to Salmeterol/fluticasone
Drug: Placebo to salbutamol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Minutes Post-dose [ Time Frame: Five Minutes Post Dose ] [ Designated as safety issue: No ]
    FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.


Enrollment: 89
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
Experimental: Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut
Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other Names:
  • Arcapta
  • Neohaler
Drug: Salmeterol/fluticasone (50/500 μg)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Salbutamol (200 µg)
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
Drug: Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
Drug: Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI
Experimental: Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo
Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other Names:
  • Arcapta
  • Neohaler
Drug: Salmeterol/fluticasone (50/500 μg)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Salbutamol (200 µg)
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
Drug: Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
Drug: Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI
Experimental: Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg
Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other Names:
  • Arcapta
  • Neohaler
Drug: Salmeterol/fluticasone (50/500 μg)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Salbutamol (200 µg)
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
Drug: Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
Drug: Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI
Experimental: Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut
Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other Names:
  • Arcapta
  • Neohaler
Drug: Salmeterol/fluticasone (50/500 μg)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Salbutamol (200 µg)
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
Drug: Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
Drug: Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI
Experimental: Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg
Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Other Names:
  • Arcapta
  • Neohaler
Drug: Salmeterol/fluticasone (50/500 μg)
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Salbutamol (200 µg)
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Drug: Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
Drug: Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
Drug: Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI

  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 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 Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Berlin, Germany
Novartis Investigator Site
Borstel, Germany
Novartis Investigative site
Dortmund, Germany
Novartis Investigative site
Hamburg, Germany
Novartis Investigative site
Hannover, Germany
Novartis Investigative site
Mainz, Germany
Novartis Investigator Site
Potsdam, Germany
Novartis Investigative site
Wiesbaden, 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: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00669617     History of Changes
Other Study ID Numbers: CQAB149B2307, EUDRACT: 2007-006189-14
Study First Received: April 28, 2008
Results First Received: July 22, 2011
Last Updated: September 7, 2011
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 27, 2014