Last updated: 11/20/2023 05:40:17
An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of RELVAR administered in Korean subjects in usual practice.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of RELVAR administered in Korean subjects in usual practice.
Trial description: RELVAR has been approved on 01, July, 2014 in Korea. We aim to conduct PMS to monitor the safety and effectiveness based on the data collected in a real world clinical practice according to PMS regulation. RELVAR and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
- Minimum of one follow-up after administrating RELVAR in order to assess safety
Timeframe: Minimum of one follow-up
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
3000
Primary completion date:
2020-02-07
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Eun-Yeong Cho, Jung-Eun Cho, Seung Hun Jang, Ki-Eun Hwang. Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea. Drug safety. 2023-Aug-31;
DOI :10.1007/s40264-023-01337-w PMID: 37651085
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2015 to July 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
Not applicable
- RELVAR 100 ELLIPTA
- The regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonists and inhaled corticosteroid) is appropriate: subjects not adequately controlled with inhaled corticosteroids and 'as needed’ inhaled short-acting beta2-agonists.
- Subject with acute Asthma or acute exacerbation in COPD, for which a short-acting bronchodilator is required at the time of the recruitment visit
- Subject who experienced hypersensitivity to the active substances or to any of the excipients
Inclusion and exclusion criteria
Inclusion criteria:
- RELVAR 100 ELLIPTA
- The regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonists and inhaled corticosteroid) is appropriate: subjects not adequately controlled with inhaled corticosteroids and 'as needed’ inhaled short-acting beta2-agonists. -Adult subjects (19 years and older) who have chronic obstructive pulmonary disease (COPD
- Pulmonary Function Test: post bronchodilator, FEV1/FVC < 0.7) with exacerbation history after regular bronchodilator treatment -Subjects who will administer RELVAR according to locally approved prescribing information RELVAR 200 ELLIPTA -The regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonists and inhaled corticosteroid) is appropriate: subjects not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists.
- Subjects who will administer RELVAR according to locally approved prescribing information
Exclusion criteria:
- Subject with acute Asthma or acute exacerbation in COPD, for which a short-acting bronchodilator is required at the time of the recruitment visit
- Subject who experienced hypersensitivity to the active substances or to any of the excipients
- Subject with severe hypersensitivity to milk proteins
- Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2020-02-07
Actual study completion date
2020-02-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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