Arnuity® Ellipta® Drug Use Investigation

Asthma Clinical Trial

Official title:

Arnuity Ellipta Drug Use Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184480
• Other study ID #: 207580
• Status: Completed
• Start date: August 19, 2017
• Est. completion date: March 17, 2021

Study information

• Verified date: April 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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