Arnuity® Ellipta® Drug Use Investigation

NCT ID: NCT03184480

Last Updated: 2021-04-26

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

COMPLETED

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-19

Study Completion Date

2021-03-17

Brief Summary

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The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as "Arnuity") in daily clinical practice. The investigation will include subjects with a diagnosis of asthma bronchial who are naïve to ARNUITY. The investigator will monitor the information about safety and effectiveness of ARNUITY for one year from the start date of ARNUITY administration and Pneumonia will be considered as the priority investigation matter. 300 subjects, from approximately 150 medical institutions, will be included in this analysis. ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SUBJECTS RECEIVING ARNUITY ELLIPTA

Subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated, who are naïve to Arnuity will be included.

Arnuity Ellipta

Intervention Type DRUG

The active component of Arnuity Ellipta is fluticasone furoate and it is indicated for the treatment of bronchial asthma. Post-marketing investigation of ARNUITY ELLIPTA will be carried out in this analysis.

Interventions

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Arnuity Ellipta

The active component of Arnuity Ellipta is fluticasone furoate and it is indicated for the treatment of bronchial asthma. Post-marketing investigation of ARNUITY ELLIPTA will be carried out in this analysis.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The investigation will include subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Nagasaki, , Japan

Site Status

Countries

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Japan

Other Identifiers

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207580

Identifier Type: -

Identifier Source: org_study_id

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