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

NCT03595930 | Completed

• 1 other identifier: 207435
• Study Type: observational
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

ARNUITY; Effectiveness; Asthma; Post-marketing surveillance; Safety

Outcome Measures

Primary Outcomes (8)

• Incidence rate of adverse events (AEs) after ARNUITY administration

  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.

  Up to 22months

• Incidence rates of unexpected AEs and adverse drug reactions (ADRs)

  An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.

  Up to 22 months

• Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)

  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.

  Up to 22 months

• Number of subjects with abnormal findings as assessed by physician's effectiveness assessment

  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.

  Week 24

• Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration

  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.

  Week 0, Week 24

• Change in Forced Vital Capacity (FVC) before and after ARNUITY administration

  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.

  Week 0, Week 24

• Change in FEV1/FVC ratio before and after ARNUITY administration

  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

  Week 0, Week 24

• Changes in the asthma symptom control results before and after ARNUITY administration

  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'.

  Week 0, Week 24

Study Arms (1)

Subjects who received ARNUITY

This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label.

Drug: Arnuity

Interventions

Arnuity DRUG

ARNUITY consist of Fluticasone Furoate, is an Inhaled corticosteroids (ICS) medicine taken as one inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older.

Subjects who received ARNUITY

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seoul, South Korea

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 22 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: September 21, 2018
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

KR (1)