Asthma
Conditions
Keywords
Drug Use Investigation, GW685698, asthma, Post-marketing surveillance, ARNUITY ELLIPTA
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.
Interventions
DRUGArnuity 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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Japan
Outcome results
None listed