A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

NCT ID: NCT01860066

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-09-30

Brief Summary

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Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QVA149

QVA149 study medication kit will contain blister strips and a unique inhaler. Patients will be instructed to inhale their medication twice a day for 12 weeks.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 via inhaler twice a day

fluticasone/salmeterol

Fluticasone/salmeterol study medication kit will contain an inhaler in the manufacturer's device. Patients will be instructed to inhale their medication twice a day for 12 weeks.

Group Type ACTIVE_COMPARATOR

fluticasone/salmeterol

Intervention Type DRUG

fluticasone/salmeterol via inhaler twice a day

Interventions

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QVA149

QVA149 via inhaler twice a day

Intervention Type DRUG

fluticasone/salmeterol

fluticasone/salmeterol via inhaler twice a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Age \>= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 \>=30% and \<80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF \>450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.
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

Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

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Novartis Investigative Site

Antwerp, , Belgium

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Genk, , Belgium

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Novartis Investigative Site

Gilly, , Belgium

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Novartis Investigative Site

Hasselt, , Belgium

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Novartis Investigative Site

Jambes, , Belgium

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Novartis Investigative Site

Barranquilla, , Colombia

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Novartis Investigative Site

Florida Blanca, , Colombia

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Novartis Investigative Site

Medellín, , Colombia

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Novartis Investigative Site

Cvikov, Czech Republic, Czechia

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Jindřichův Hradec, Czech Republic, Czechia

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Karlovy Vary, Czech Republic, Czechia

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Kuřim, Czech Republic, Czechia

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Novartis Investigative Site

Pardubice, Czech Republic, Czechia

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Novartis Investigative Site

Teplice, Czech Republic, Czechia

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Novartis Investigative Site

Kyjov, CZE, Czechia

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Novartis Investigative Site

Guntur, Andhra Pradesh, India

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Novartis Investigative Site

Ahmedabad, Gujarat, India

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Novartis Investigative Site

Faridabad, Haryana, India

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Novartis Investigative Site

Karamsad, India, India

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Novartis Investigative Site

Bangalore, Karnataka, India

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Novartis Investigative Site

Nagpur, Maharashtra, India

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Novartis Investigative Site

Pune, Maharashtra, India

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Novartis Investigative Site

Jaipur, Rajasthan, India

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Countries

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United States Argentina Belgium Colombia Czechia India

Other Identifiers

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CQVA149A2328

Identifier Type: -

Identifier Source: org_study_id