Last updated: 07/23/2024 13:20:29

Post-marketing study of Umeclidinium (UMEC)/Vilanterol (VI) in Chinese participants

GSK study ID
212300
See study documents
Clinicaltrials.gov ID
Not applicable
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: Post-Marketing Observational Study to Evaluate Safety Profile of Umeclidinium/Vilanterol Treatment in Chinese Patients
Trial description: ANORO ELLIPTA™ an inhaled combination of UMEC and VI, administered once daily via the dry powder ELLIPTA inhaler. This is observational study, which will include participants who have been prescribed ANORO ELLIPTA or will start to administer ANORO ELLIPTA. This post-marketing intensive monitoring study will collect and evaluate the safety profile of Chinese participants when using UMEC/VI 62.5/25 micrograms (mcg) via ELLIPTA inhaler device in clinical practice. At least 3000 participants from hospitals and pharmacy for intensive drug monitoring will be included. The maximum observation duration will be 24 weeks with 4 visits. An Electronic Data Capture (EDC) system will be used in this study. ANORO ELLIPTA is a trademark of the GlaxoSmithKline Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Chinese participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Week 24

Number of Chinese participants with known adverse drug reactions (ADRs)

Timeframe: Up to Week 24

Number of elderly Chinese participants with known ADRs

Timeframe: Up to Week 24

Number of renal impaired Chinese participants with known ADRs

Timeframe: Up to Week 24

Number of hepatic impaired Chinese participants with known ADRs

Timeframe: Up to Week 24

Number of pregnant Chinese participants with known ADRs

Timeframe: Up to Week 24

Number of Chinese participants with unexpected ADRs

Timeframe: Up to Week 24

Number of Chinese participants with important identified events

Timeframe: Up to Week 24

Number of Chinese participants with important potential events

Timeframe: Up to Week 24

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
3000
Primary completion date:
2022-12-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
X D Mu, X M Li, X P He, L H Jia, Y H Guan, F C An, L P Chen, Q Jia, A L Xiao, L C Zhang, Z H Xiao, Y M Wang, W Guan, T T Liu, L Su. [Safety of umeclidinium/vilanterol in Chinese patients in a real-world setting: a prospective, multicenter, single-arm, observational study].. Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases. 2024-Jul-12;47(7): 632-637. DOI: 10.3760/cma.j.cn112147-20231124-00339 PMID: 38955748
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
NA
Study date(s)
December 2020 to July 2022
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants who is administering ANORO ELLIPTA or initiate ANORO ELLIPTA for appropriate medical use.
  • Participant or the participant's legal representative is willing and able to understand and provide signed and dated informed consent.
  • Participants who are not appropriate to be included by any reason judged by investigators.
  • Participants who are allergic to ANORO ELLIPTA.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants who is administering ANORO ELLIPTA or initiate ANORO ELLIPTA for appropriate medical use.
  • Participant or the participant's legal representative is willing and able to understand and provide signed and dated informed consent.
  • Participants must provide reliable contact method, which includes home phone or cell phone for the follow up visits.
  • Participants must have the ability to comply to study procedures.
Exclusion criteria:
  • Participants who are not appropriate to be included by any reason judged by investigators.
  • Participants who are allergic to ANORO ELLIPTA.

Trial location(s)

This study does not involve prospective enrollment of participants.

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
2022-12-07
Actual study completion date
2022-12-07

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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