Last updated: 03/05/2025 07:50:13

Post-marketing surveillance (PMS) study to observe the safety and effectiveness of ARNUITY in Asthma subjects in a real world setting

GSK study ID
207435
See study documents
Clinicaltrials.gov ID
NCT03595930
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence rate of adverse events (AEs) after ARNUITY administration

Timeframe: Up to 22months

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

Timeframe: Up to 22 months

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

Timeframe: Up to 22 months

Number of subjects with abnormal findings as assessed by physician’s effectiveness assessment

Timeframe: Week 24

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

Timeframe: Week 0, Week 24

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

Timeframe: Week 0, Week 24

Change in FEV1/FVC ratio before and after ARNUITY administration

Timeframe: Week 0, Week 24

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

Timeframe: Week 0, Week 24

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Arnuity
    • Enrollment:
    668
    Primary completion date:
    2020-22-07
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    September 2018 to July 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • 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 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
    Inclusion and exclusion criteria
    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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 100-032
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2020-22-07
    Actual study completion date
    2020-22-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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