Efficacy, Safety and Tolerability of Once-Daily (o.d.) Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily (b.i.d.) as Active Control - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00393458

Purpose

This study is designed to assess the efficacy and long-term safety data for the 300 and 600 µg doses of indacaterol when delivered via a single dose dry powder inhaler (SDDPI) in patients with COPD. Patients are randomized to receive either indacaterol 300 µg o.d., indacaterol 600 µg o.d., formoterol 12 µg b.i.d. or placebo.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol (300 µg o.d.) Drug: Indacaterol (600 µg o.d.) Drug: formoterol 12ug bid Drug: placebo	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	A 52-Week Treatment, Multicenter, Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of Indacaterol (300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12µg b.i.d.) as an Active Control

Further study details as provided by Novartis:

Primary Outcome Measures:

24 h post-dose lung function measured by a special test called "forced expiratory volume in one second" (FEV1) after 12 weeks of treatment

Secondary Outcome Measures:

Percentage of "days of poor control" reported by the patient over the 52 week randomized treatment period
Total score of the St. George's Respiratory Questionnaire after 12 weeks of treatment
Time to first COPD exacerbation during the 52 week randomized treatment period

Estimated Enrollment:	1716
Study Start Date:	October 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Indacaterol (300 µg o.d.)
2: Active Comparator	Drug: Indacaterol (600 µg o.d.)
3: Active Comparator	Drug: formoterol 12ug bid
4: Placebo Comparator	Drug: placebo

Eligibility

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

Criteria

Inclusion Criteria:

Male and female patients at least 40 years of age who have signed an informed consent and have a diagnosis of COPD
Smoking history of at least 20 pack years
Pre-bronchodilator FEV1 less than 65% of predicted normal value and at least 0.75 L.
Pre-bronchodilator FEV1/FVC less than 70%

Exclusion Criteria:

A history of asthma or a COPD diagnosis before the age of 40
Hospitalization for COPD exacerbation within the previous 6 weeks
Respiratory tract infection within 6 weeks
Use of long-term oxygen therapy
Diabetes type I or uncontrolled diabetes type II
Clinically relevant laboratory abnormality or clinically significant condition
Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393458

Show 184 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Investigator Site

Novartis

More Information

Responsible Party:	novartis ( external affairs )
Study ID Numbers:	CQAB149B2334
Study First Received:	October 25, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00393458
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: Federal Agency for Medicinal Products and Health Products; Switzerland: Federal Office of Public Health; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Ecuador: Public Health Ministry; Egypt: Ministry of Health and Population; Spain: Spanish Agency of Medicines; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Korea: Food and Drug Administration; Lithuania: State Medicine Control Agency - Ministry of Health; Latvia: State Agency of Medicines; Netherlands: Medicines Evaluation Board (MEB); Peru: Ministry of Health; Romania: Ministry of Public Health; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; Turkey: Ministry of Health

Keywords provided by Novartis:

Chronic obstructive pulmonary disease
COPD
indacaterol
long acting β2 agonist
Chronic Obstructive Pulmonary Disease (COPD)

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Formoterol
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
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 January 14, 2009