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

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol 150 μg Drug: Indacaterol 300 μg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Indacaterol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	50
Study Start Date:	December 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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: 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.	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: 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.	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: 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.	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).

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403845

Locations

Japan
Novartis Investigative site
Kasukabe, Japan
Novartis Investigator Site
Kishiwada, Japan
Novartis Investigative Site
Kurume, Japan
Novartis Investigative Site
Obihiro, Japan
Novartis Investigative Site
Sagamihara, Japan
Novartis Investigative Site
Sapporo, Japan
Novartis Investigator Site
Tokyo, Japan
Novartis Investigative Site
Wakayama, Japan

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals Japan

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00403845 History of Changes
Other Study ID Numbers:	CQAB149B1202
Study First Received:	November 24, 2006
Results First Received:	July 22, 2011
Last Updated:	July 22, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

chronic obstructive pulmonary disease
COPD
QAB149
indacaterol
long acting β2-agonist

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013