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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Asthma

Treatments: Drug: Arnuity

Study type: Observational

Funder types: Industry

Identifiers

NCT03595930

207435

Details and patient eligibility

About

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.

Enrollment: 668 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

668 participants in 1 patient group

Subjects who received ARNUITY

Description:

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

Treatment:

Drug: Arnuity