Last updated: 03/04/2025 09:20:52
Arnuity® Ellipta® Drug Use Investigation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Arnuity Ellipta Drug Use Investigation
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs
Timeframe: One year from the start of Arnuity administration
Number of subjects with pneumonia
Timeframe: One year from the start of Arnuity administration
Response rate based on global assessment of effectiveness
Timeframe: One year from the start of Arnuity administration
Total ACT score
Timeframe: One year from the start of Arnuity administration
Secondary outcomes:
Not applicable
Interventions:
Drug: Arnuity Ellipta
Enrollment:
336
Observational study model:
Cohort
Primary completion date:
2021-17-03
Time perspective:
Prospective
Clinical publications:
Megumi Koyano, Yoriko Morioka, Kyomi Kanaya, Yasuko Iinuma, Daisaku Yasui, Naohiro Takahashi. Evaluation of the Safety and Effectiveness of Fluticasone Furoate Dry Powder Inhaler in Patients with Bronchial Asthma - Report of the Drug Use Investigation Results. Ther Res. 2022;43(4):295-309
DOI:NULL
PMID:NULL
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
August 2017 to March 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- The investigation will include subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.
- Not applicable
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2021-17-03
Actual study completion date
2021-17-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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