Arnuity® Ellipta® Drug Use Investigation

Completed

• Conditions: Asthma
• Interventions: Drug: Arnuity Ellipta

• Registration Number: NCT03184480
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Study Start: 2017-08-19
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUBJECTS RECEIVING ARNUITY ELLIPTA	Arnuity Ellipta	Subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated, who are naïve to Arnuity will be included.

Primary Outcome Measures

Name	Time	Method
Total ACT score	One year from the start of Arnuity administration	ACT is a simple 5-question tool to evaluate the progression of asthma. Investigator will record the information from the ACT completed by subjects at the start of Arnuity administration, at Month 3, Year 1 from the start of Arnuity administration, or at the time of withdrawal from/termination of administration.
Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs	One year from the start of Arnuity administration	The investigator will collect the information about all AEs (e.g., a disease, symptom, abnormal laboratory value) occurring after the start of Arnuity administration, regardless of whether or not Arnuity is related to an AE.
Response rate based on global assessment of effectiveness	One year from the start of Arnuity administration	The response rate is the proportion of subjects assessed as "effective". Effectiveness will be comprehensively assessed based on the course of subjective and clinical symptoms and changes in Asthma Control Test (ACT) scores, etc. from the start date of administration to the end of the observation period.
Number of subjects with pneumonia	One year from the start of Arnuity administration	Pneumonia will be considered as priority investigation matter for this investigation and its occurrence will be monitored throughout the study period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Nagasaki, Japan