Dose Ranging Study for Indacaterol in Japanese Asthma Patients - Full Text View

Purpose

This study is designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300 & 600 µg) in Japanese asthma patients so that an optimal dose, or doses, can be chosen for testing in later studies.

Condition	Intervention	Phase
Asthma	Drug: Indacaterol maleate Drug: Placebo Drug: Salmeterol xinafoate	Phase II

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

QAB 149 Indacaterol Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo Controlled, 4-Period 4-Treatment Crossover, Multi-Center, Single Dose, Dose Ranging Study Followed by a Single Day's Treatment With Open Label Salmeterol Bid (100 µg/Day), to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300 & 600 µg) Delivered Via SDDPI in Japanese Asthma Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Lung function measured from 22-24 hours after having taken medication, by a special test "forced expiratory volume in 1 second" (FEV1). [ Time Frame: Day 1, 22-24 hours post-dose ] [ 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: Day 1, from 5 min to 24 h post-dose ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	November 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Indacaterol 150 µg via single-dose dry powder inhaler (SDDPI)	Drug: Indacaterol maleate
2: Experimental Indacaterol 300 µg via SDDPI	Drug: Indacaterol maleate
3: Experimental Indacaterol 600 µg via SDDPI	Drug: Indacaterol maleate
4: Placebo Comparator Placebo via SDDPI	Drug: Placebo
5: Active Comparator Salmeterol 50 µg twice daily via multi-dose dry powder inhaler	Drug: Salmeterol xinafoate

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female Japanese asthmatic patients aged 18 to 75 years old.

Exclusion Criteria:

Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to Visit 1 or during screening period.
Patients who have used tobacco products within 6 months prior to Visit 1 or have a smoking history of greater than 10 pack years
Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin
Pregnant or nursing (lactating) women.
Patients who have had treatment with disallowed medications including investigational drug.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403754

Locations


Japan
	Novartis
	Tokyo, Japan
	Novartis Investigative Site
	Kasukabe, Japan
	Novartis Investigative Site
	Tokyo, Japan
	Novartis Investigator Site
	Suita, Japan
	Novartis Investigator Site
	Yokohama, Japan
	Novartis Investigator Site
	Wakayama, Japan
	Novartis Investigative Site
	Shimotsuga, Japan
	Novartis Investigator Site
	Kishiwada, Japan

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis Pharmaceuticals Japan	Novartis Pharmaceuticals Japan

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAB149A1202
First Received:	November 23, 2006
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00403754
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

asthma, QAB149, indacaterol, long acting β2-agonist, bronchodilator

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00403754