Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting

Completed

• Conditions: Asthma
• Interventions: Drug: Arnuity

• Registration Number: NCT03595930
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-23
• Study Start: 2018-09-21
• Primary Completion: 2020-07-22
• Study Completion: 2020-07-22
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who received ARNUITY	Arnuity	This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label.

Primary Outcome Measures

Name	Time	Method
Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)	Up to 22 months	A SAE refers to any one of the following adverse events, which: results in death or is life-threatening; results in or prolongs hospitalization; results in persistent or serious disability or incapacity; results in a birth defect or anomaly; or is an important medical event. SADR is defined a SAE whose causal relationship with the product cannot be ruled out.
Change in Forced Vital Capacity (FVC) before and after ARNUITY administration	Week 0, Week 24	The physicians shall collect FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FVC results before and after administration of the product shall be analyzed using a paired t-test.
Change in FEV1/FVC ratio before and after ARNUITY administration	Week 0, Week 24	The physicians shall collect FEV1/FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1/ FVC ratio before and after administration of the product shall be analyzed using a paired t-test
Incidence rates of unexpected AEs and adverse drug reactions (ADRs)	Up to 22 months	An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.
Incidence rate of adverse events (AEs) after ARNUITY administration	Up to 22months	An AE is defined as any undesirable, unintended signs (e.g., abnormal laboratory findings), symptoms, or disease that may occur after administration or during use of the product, and does not necessarily have to have a causal relationship with the product.
Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration	Week 0, Week 24	The physicians shall collect FEV1 data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1 results before and after administration of the product shall be analyzed using a paired t-test.
Changes in the asthma symptom control results before and after ARNUITY administration	Week 0, Week 24	The physician shall collect the asthma symptom control results at Week 0 and Week 24 after Arnuity administration, based on the symptoms the subjects experienced for the past 4 weeks. The results of the asthma symptom control shall be categorized into 'Controlled', 'Partly Controlled', and 'Uncontrolled'.
Number of subjects with abnormal findings as assessed by physician's effectiveness assessment	Week 24	For the subjective assessment of effectiveness, the physicians shall assess physician's effectiveness assessment at Week 24 after administration of Arnuity, based on the pulmonary function test and/or asthma symptom control.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of