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

Purpose

The study is designed to obtain data about the efficacy and safety of three doses of indacaterol (150, 300 and 600 µg) in Japanese patients with COPD so that optimal dose(s) can be chosen for testing in later studies.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: indacaterol maleate Drug: placebo	Phase II

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

QAB 149 Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled, 4-Period 4-Treatment Crossover, Multi-Center, Dose Ranging Study, to Assess the Efficacy and Safety of 3 Single 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)

Further study details as provided by Novartis:

Primary Outcome Measures:

Lung function measured 22 to 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second" (FEV1) [ Time Frame: 22-24 h post-dose on Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 5 min - 24h, Day 1 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental	Drug: indacaterol maleate Indacaterol 150 µg single dose, once-daily
2: Experimental	Drug: indacaterol maleate Indacaterol 300 µg single dose, once-daily
3: Experimental	Drug: indacaterol maleate Indacaterol 600 µg single dose, once-daily
4: Placebo Comparator	Drug: placebo placebo, single dose, once-daily

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 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 may apply

Contacts and Locations

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

Locations


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

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis Pharmaceuticals Japan	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAB149B1202
First Received:	November 24, 2006
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00403845
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Chronic obstructive pulmonary disease

COPD

QAB149

indacaterol

long acting β2-agonist

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Maleic acid

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00403845