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12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

NCT ID: NCT01232894

Last Updated: 2013-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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indacaterol COPD Long-acting beta2-agonist (LABA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indacaterol

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Long-acting beta2-agonist

Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy

Group Type ACTIVE_COMPARATOR

Long-acting beta2-agonist

Intervention Type DRUG

Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Interventions

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Indacaterol

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Intervention Type DRUG

Long-acting beta2-agonist

Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
* Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

Exclusion Criteria

* Patients with a history of asthma
* Patients who are currently being treated for COPD with tiotropium (Spiriva®)
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of certain cardiovascular comorbid conditions
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Afula, , Israel

Site Status

Novartis Investigative Site

Ashkelon, , Israel

Site Status

Novartis Investigative Site

Holon, , Israel

Site Status

Novartis Investigative Site

Jerusalem, , Israel

Site Status

Novartis Investigative Site

Kfar Saba, , Israel

Site Status

Novartis Investigative Site

Petah Tikva, , Israel

Site Status

Novartis Investigative Site

Rehovot, , Israel

Site Status

Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CQAB149BIL01

Identifier Type: -

Identifier Source: org_study_id