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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00615030

Purpose

This study is being conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Indacaterol Drug: Salmeterol Drug: placebo	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Indacaterol Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

Further study details as provided by Novartis:

Primary Outcome Measures:

Trough forced expiratory volume in 1 second (FEV1) following 14 days of evening dosing of 300 µg indacaterol versus placebo. (Trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min following day 14 evening dose).

Secondary Outcome Measures:

Safety of indacaterol 300µg dosed in the evening with regard to electrocardiograms (ECGs), laboratory tests, blood pressure, heart rate, and adverse events
Descriptive comparison of trough FEV1 of indacaterol 300µg dosed in the morning versus placebo after 14 days of treatment, with trough FEV1 of indacaterol 300µg dosed in the evening versus placebo after 14 days of treatment

Estimated Enrollment:	78
Study Start Date:	January 2008
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 dosed in the evening via SDDPI
2: Active Comparator	Drug: Indacaterol 300 µg dosed in the morning via SDDPI
3: Active Comparator	Drug: Salmeterol 50 µg twice daily delivered via manufacturer's dry powder inhaler
4: Placebo Comparator	Drug: placebo placebo to indacaterol and salmeterol

Eligibility

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

Criteria

Inclusion criteria:

Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:
Smoking history of at least 20 pack years
Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

Exclusion criteria:

Pregnant or lactating females
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long term oxygen therapy (>15 h a day)
Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
Patients with history of asthma (with further criteria)
Patients with Type I or uncontrolled type II diabetes.
Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
Patient with a history with long QT syndrome or whose QTc interval is prolonged
Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
Patients who have had treatment with an investigational drug (with further criteria)
Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
Patients with known history of non compliance to medication
Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615030

Locations

France
Novartis Investigative Site
Beuvry, France
Novartis Investigative Site
Nantes, France
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Leipzig, Germany
Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

+ 41 61 324 1111

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAB149B2305
Study First Received:	February 1, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00615030
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

COPD, bronchodilator, long acting beta agonist, LABA

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
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