Arnuity® Ellipta® Drug Use Investigation

NCT03184480 | Completed

• 1 other identifier: 207580
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Drug Use Investigation; GW685698; asthma; Post-marketing surveillance; ARNUITY ELLIPTA

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs

  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.

  One year from the start of Arnuity administration

• Number of subjects with pneumonia

  Pneumonia will be considered as priority investigation matter for this investigation and its occurrence will be monitored throughout the study period.

  One year from the start of Arnuity administration

• Response rate based on global assessment of effectiveness

  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.

  One year from the start of Arnuity administration

• Total ACT score

  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.

  One year from the start of Arnuity administration

Study Arms (1)

SUBJECTS RECEIVING ARNUITY ELLIPTA

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

Drug: Arnuity Ellipta

Interventions

Arnuity Ellipta 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.

SUBJECTS RECEIVING ARNUITY ELLIPTA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigation will assess the information about safety and effectiveness of Arnuity in approximately 300 subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Hokkaido, 050-0074, Japan

Location

GSK Investigational Site

Nagasaki, 852-8105, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: August 19, 2017
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

JP (2)