Skip to main content
OpenTrials
Completed

NCT Number: NCT03595930

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence rate of adverse events (AEs) after ARNUITY administration

    Time frame: 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.

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

    Time frame: Up to 22 months

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

  3. Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  7. Change in FEV1/FVC ratio before and after ARNUITY administration

    Time frame: 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

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

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.