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A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

NCT ID: NCT02566031

Last Updated: 2019-09-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-23

Study Completion Date

2018-06-04

Brief Summary

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To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

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Detailed Description

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Conditions

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COPD

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 and glycopyrronium (QVA149)

QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks

Group Type EXPERIMENTAL

Indacaterol and glycopyrronium (QVA149)

Intervention Type DRUG

Capsules for inhalation delivered via SDDPI

Tiotropium

Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Capsules for inhalation delivered via HandiHaler® device

Interventions

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Indacaterol and glycopyrronium (QVA149)

Capsules for inhalation delivered via SDDPI

Intervention Type DRUG

Tiotropium

Capsules for inhalation delivered via HandiHaler® device

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC \< 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
* Patients with CAT score ≥ 10 at Visit 0 and Visit 1.
* Patients who are on and have been on tiotropium monotherapy for the past 3 months.
* 0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria

* Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.
* COPD exacerbation between Visit 0 and 1.
* Patients with concomitant pulmonary disease
* Patients with a history of respiratory infection within 4 weeks prior to Visit 0.
* Prior or current diagnosis of asthma.
* Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA
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

Locations

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Novartis Investigative Site

Chuncheon, Gangwon-do, South Korea

Site Status

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Site Status

Novartis Investigative Site

Anyang-si, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Guri-si, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Koyang, Kyunggi, South Korea

Site Status

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Site Status

Novartis Investigative Site

Gwangju, , South Korea

Site Status

Novartis Investigative Site

Incheon, , South Korea

Site Status

Novartis Investigative Site

Incheon, , South Korea

Site Status

Novartis Investigative Site

Jeju City, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3.

Reference Type DERIVED
PMID: 28228162 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CQVA149AKR01

Identifier Type: -

Identifier Source: org_study_id

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