Clinical trial NCT03595930: Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting
Official title: An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: ARNUITY
Effectiveness
Asthma
Post-marketing surveillance
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 668
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label. The safety analysis population shall consist of subjects who have administered at least one dose of ARNUITY and have received at least one safety assessment. The effectiveness analysis population shall consist of subjects who have completed the physician's effectiveness assessment (i.e., improved, unchanged, exacerbated, or un-assessable) based on the results of the pulmonary function test or asthma symptom control after administering ARNUITY for 24 weeks (or longer).

Brief summary: This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.


Eligibility criteria: Inclusion Criteria:

* Pediatric subjects older than 12 years of age and adult subjects with asthma
* Subjects who will administer ARNUITY in accordance with the product information approved in Korea
* Subjects who have signed the informed consent form for the PMS

Exclusion Criteria:

* Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment
* Subjects who have any known hyper-sensitivity to the drug or its ingredients
* Subjects who have severe hypersensitive reactions to milk proteins
* Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

Primary outcomes:
measure: Incidence rate of adverse events (AEs) after ARNUITY administration
timeFrame: Up to 22months
measure: Incidence rates of unexpected AEs and adverse drug reactions (ADRs)
timeFrame: Up to 22 months
measure: Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)
timeFrame: Up to 22 months
measure: Number of subjects with abnormal findings as assessed by physician's effectiveness assessment
timeFrame: Week 24
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration
timeFrame: Week 0, Week 24
measure: Change in Forced Vital Capacity (FVC) before and after ARNUITY administration
timeFrame: Week 0, Week 24
measure: Change in FEV1/FVC ratio before and after ARNUITY administration
timeFrame: Week 0, Week 24
measure: Changes in the asthma symptom control results before and after ARNUITY administration
timeFrame: Week 0, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: