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Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01285492

Last Updated: 2013-12-27

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (\[glycopyrronium bromide\]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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COPD QVA149 NVA237 indacaterol combination bronchodilator

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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QVA149

QVA149 110/50 μg once a day (o.d)

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1

Tiotropium

tiotropium 18 μg o.d.

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Tiotropium (18 μg o.d.), delivered via Handihaler®

Interventions

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QVA149

QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1

Intervention Type DRUG

Tiotropium

Tiotropium (18 μg o.d.), delivered via Handihaler®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
* Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
* Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2.

Exclusion Criteria

* Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
* Patients requiring long term oxygen therapy
* Patients who have had a lower respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years
* Patients with a history of certain cardiovascular comorbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines
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

Anjo, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nishio, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Akita, Akita, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kasuga, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kurume, Fukuoka, Japan

Site Status

Novartis Investigative Site

Yanagawa, Fukuoka, Japan

Site Status

Novartis Investigative Site

Asahikawa, Hokkaido, Japan

Site Status

Novartis Investigative Site

Obihiro, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Himeji, Hyōgo, Japan

Site Status

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Takamatsu, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kochi, Kochi, Japan

Site Status

Novartis Investigative Site

Kōshi, Kumamoto, Japan

Site Status

Novartis Investigative Site

Matsusaka, Mie-ken, Japan

Site Status

Novartis Investigative Site

Ueda, Nagano, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Sayama, Osaka, Japan

Site Status

Novartis Investigative Site

Takatsuki, Osaka, Japan

Site Status

Novartis Investigative Site

Toyonaka, Osaka, Japan

Site Status

Novartis Investigative Site

Kawaguhi-city, Saitama, Japan

Site Status

Novartis Investigative Site

Hamamatsu, Shizuoka, Japan

Site Status

Novartis Investigative Site

Fuchū, Tokyo, Japan

Site Status

Novartis Investigative Site

Meguro City, Tokyo, Japan

Site Status

Novartis Investigative Site

Wakayama, Wakayama, Japan

Site Status

Novartis Investigative Site

Yamagata, Yamagata, Japan

Site Status

Novartis Investigative Site

Ube, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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CQVA149A1301

Identifier Type: -

Identifier Source: org_study_id