Arnuity Ellipta Drug Use Investigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 336
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SUBJECTS RECEIVING ARNUITY ELLIPTA
Subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated, who are naïve to Arnuity will be included.
Intervention: Arnuity Ellipta (Drug)
Outcomes
Primary Outcomes
Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs
Time Frame: 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.
Total ACT score
Time Frame: 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.
Response rate based on global assessment of effectiveness
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported