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

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00876694

Purpose

This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Indacaterol 300 µg Drug: Salmeterol 50 µg	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Salmeterol Salmeterol xinafoate Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A 52-Week Treatment, Multi-Center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Novartis:

Primary Outcome Measures:

To study the long term safety and tolerability (particularly with regard to ECG, laboratory tests, vital signs and adverse events) of indacaterol (300 µg o.d.) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the efficacy of indacaterol (300 µg o.d.) and salmeterol (50 µg b.i.d.) [ Time Frame: 4, 8, 12, 24, 36, 44 and 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	March 2009
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Indacaterol 300 µg: Experimental	Drug: Indacaterol 300 µg Indacaterol 300 µg once daily (od) via SDDPI
Salmeterol 50 µg: Active Comparator	Drug: Salmeterol 50 µg Salmeterol 50 µg twice daily (bid) via Diskus®

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

Smoking history of at least 20 pack-years
Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876694

Contacts

Contact: Novartis Pharmaceuticals

+81-3-3797-8748

Locations

Japan
Novartis Investigator site	Recruiting
Sapporo, Japan
Novartis Investigator Site	Recruiting
Morioka, Japan
Novartis Investigator Site	Recruiting
Sapporo, Japan
Novartis Investigator Site	Recruiting
Asahikawa, Japan
Novartis Investigator Site	Recruiting
Obihiro, Japan
Novartis Investigator Site	Recruiting
Bunkyo-ku, Japan
Novartis Investigator Site	Recruiting
Sumida-ku, Japan
Novartis Investigator Site	Recruiting
Setagaya-ku, Japan
Novartis Investigator Site	Recruiting
Kawasaki, Japan
Novartis Investigator Site	Recruiting
Yokohama, Japan
Novartis Investigator Site	Recruiting
Noda, Japan
Novartis Investigator Site	Recruiting
Iwata, Japan
Novartis Investigator Site	Recruiting
Nagoya, Japan
Novartis Investigator Site	Recruiting
Gifu, Japan
Novartis Investigator Site	Recruiting
Kyoto, Japan
Novartis Investigator Site	Recruiting
Wakayama, Japan
Novartis Investigator Site	Recruiting
Sendai, Japan
Novartis Investigator Site	Recruiting
Himeji, Japan
Novartis Investigator Site	Recruiting
Hiroshima, Japan
Novartis Investigator Site	Recruiting
Ube, Japan
Novartis Investigator Site	Recruiting
Kochi, Japan
Novartis Investigator Site	Recruiting
Kitakyushu, Japan
Novartis Investigator Site	Recruiting
Koga, Japan
Novartis Investigator Site	Recruiting
Yokkaichi, Japan
Novartis Investigator Site	Recruiting
Matsusaka-city, Japan
Novartis Investigator Site	Recruiting
Sakai, Japan
Novartis Investigator Site	Recruiting
Kishiwada, Japan
Novartis Investigator Site	Recruiting
Tenri, Japan
Novartis Investigator Site	Recruiting
Yanagawa, Japan
Novartis Investigator Site	Recruiting
Kanazawa, Japan
Novartis Investigator Site	Recruiting
Nagaoka-city, Japan
Novartis Investigator Site	Recruiting
Yabu, Japan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( Novartis Direct )
Study ID Numbers:	CQAB149B1303
Study First Received:	April 3, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00876694 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

Study placed in the following topic categories:

Neurotransmitter Agents
Salmeterol
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Adrenergic Agonists

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009