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Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00403845
First received: November 24, 2006
Last updated: July 22, 2011
Last verified: July 2011

November 24, 2006
July 22, 2011
December 2006
October 2007   (final data collection date for primary outcome measure)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 22 to 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.
Lung function measured 22 to 24 hours after having taken medication, by a special test called “forced expiratory volume in 1 second” (FEV1)
Complete list of historical versions of study NCT00403845 on ClinicalTrials.gov Archive Site
  • Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 [ Time Frame: From 5 minutes to 4 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
  • Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
  • Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
FEV1 at 5, 15 and 30 min, 1, 2, 4, 8, and 12 hours post-dose; standardized FEV1 area under the curve (AUC) between 0-24hours post dose; Peak FEV1
Not Provided
Not Provided
 
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Indacaterol 150 μg
    Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
  • Drug: Indacaterol 300 μg
    Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
  • Drug: Placebo
    Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
  • Experimental: Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg
    In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol 150 μg
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
  • Experimental: Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg
    In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol 150 μg
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
  • Experimental: Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg
    In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol 150 μg
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
  • Experimental: Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo
    In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
    Interventions:
    • Drug: Indacaterol 150 μg
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female Japanese aged 40 to 75 years old
  • Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years

Exclusion Criteria:

  • History of hospitalization for COPD exacerbation within past 6 months
  • Use of long-term oxygen therapy
  • History of asthma
  • Respiratory tract infection within past 1 month
  • Consistently very high or low blood sugar
  • Clinically abnormal laboratory values or significant condition
  • History of heart failure or heart attack within past 6 months
  • History of long QT syndrome or long QT interval in electrocardiogram recorded at screening

Other protocol-defined inclusion/exclusion criteria applied to the study.

Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00403845
CQAB149B1202
No
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Pharmaceuticals Japan Novartis
Novartis
July 2011

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