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A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT00557466
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE November 13, 2007
First Posted Date  ICMJE November 14, 2007
Results First Submitted Date  ICMJE November 12, 2012
Results First Posted Date  ICMJE January 18, 2013
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline (prior to first dose) and Day 15 (24 hours after last dose) ]
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
The mean change from baseline to 24 hr post-dose of (trough) forced expiratory volume in 1 second (FEV1) after 14 days of treatment
Change History Complete list of historical versions of study NCT00557466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
  • Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose [ Time Frame: Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. ]
    FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
  • The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 [ Time Frame: Day 1 Baseline (prior to first dose) and 24 hours post-dose. ]
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
  • Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 [ Time Frame: Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. ]
    FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
  • Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose ]
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.
  • Change From Baseline in Morning and Evening Peak Expiratory Flow [ Time Frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period). ]
    The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
  • Number of Participants Using Rescue Medication [ Time Frame: Over 14 days ]
    Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
Efficacy/safety measures comparing to placebo:(trough) FEV1, peak FEV1, FEV1 and Forced Vital Capacity (FVC), FEV1 Area Under Curce (AUC), Inspiratory Capacity (IC); rescue medication use,formoterol v. placebo for efficacy variables
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD
Brief Summary This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Drug: indacaterol
    Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
  • Drug: formoterol
    Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
  • Drug: placebo to indacaterol
    Placebo TWISTHALER® device
  • Drug: placebo to formoterol
    Placebo AEROLIZER® device
  • Drug: short acting β2- agonist
    100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Study Arms  ICMJE
  • Experimental: indacaterol 62.5 μg
    Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: indacaterol
    • Drug: placebo to formoterol
    • Drug: short acting β2- agonist
  • Experimental: indacaterol 125 μg
    Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: indacaterol
    • Drug: placebo to formoterol
    • Drug: short acting β2- agonist
  • Experimental: Indacaterol 250 μg
    Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: indacaterol
    • Drug: placebo to formoterol
    • Drug: short acting β2- agonist
  • Experimental: indacaterol 500 μg
    Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: indacaterol
    • Drug: placebo to formoterol
    • Drug: short acting β2- agonist
  • Active Comparator: formoterol
    Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: formoterol
    • Drug: placebo to indacaterol
    • Drug: short acting β2- agonist
  • Placebo Comparator: placebo
    Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
    Interventions:
    • Drug: placebo to indacaterol
    • Drug: placebo to formoterol
    • Drug: short acting β2- agonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2009)
568
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2007)
390
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
  • Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

    • Smoking history of at least 10 pack years
    • Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.
    • Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

Exclusion Criteria:

  • Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
  • Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
  • Patients with a history of asthma.
  • Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
  • Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Chile,   France,   Germany,   Hungary,   Ireland,   Italy,   Latvia,   Lithuania,   Norway,   Peru,   Poland,   Romania,   South Africa,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557466
Other Study ID Numbers  ICMJE CQMF149B2201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Schering-Plough
Investigators  ICMJE
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2012

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