Trials / Completed
CompletedNCT03595930
Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting
An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 668 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-09-21
- Primary completion
- 2020-07-22
- Completion
- 2020-07-22
- First posted
- 2018-07-23
- Last updated
- 2020-08-24
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03595930. Inclusion in this directory is not an endorsement.