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

NCT03595930 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 668

Last updated 2020-08-24

No results posted yet for this study

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

Interventions

DRUG

Arnuity

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2020-07-22
Completion
2020-07-22

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595930 on ClinicalTrials.gov