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

NCT ID: NCT01834885

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WITHDRAWN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/slameterol via inhaler twice a day

Interventions

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QVA149

QVA149 via inhaler twice a day

Intervention Type DRUG

fluticasone/salmeterol

fluticasone/slameterol via inhaler twice a day

Intervention Type DRUG

Eligibility Criteria

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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.
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

Feldkirch, Austria, Austria

Site Status

Novartis Investigative Site

Grieskirchen, Austria, Austria

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Novartis Investigative Site

Hallein, Austria, Austria

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Novartis Investigative Site

Linz, Austria, Austria

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Novartis Investigative Site

Thalheim bei Wels, Austria, Austria

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Novartis Investigative Site

Wels, Austria, Austria

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Novartis Investigative Site

Berlin, Germany, Germany

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Novartis Investigative Site

Dresden, Germany, Germany

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Novartis Investigative Site

Leipzig, Germany, Germany

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Novartis Investigative Site

Potsdam, Germany, Germany

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Novartis Investigative Site

Aschaffenburg, , Germany

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Novartis Investigative Site

Bad Wörishofen, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Frankfurt, , Germany

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Novartis Investigative Site

Frankfurt, , Germany

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Novartis Investigative Site

Großhansdorf, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Hanover, , Germany

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Novartis Investigative Site

Leipzig, , Germany

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Novartis Investigative Site

Lübeck, , Germany

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Novartis Investigative Site

Münster, , Germany

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Novartis Investigative Site

Rheine, , Germany

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Countries

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United States Austria Germany

Other Identifiers

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CQVA149A2327

Identifier Type: -

Identifier Source: org_study_id