Last updated: 02/03/2021 09:10:06
Drug Use Investigation of ANORO ELLIPTA inhaler
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation of ANORO ELLIPTA inhaler
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in subjects with chronic obstructive pulmonary disease (COPD) who are treated with umeclidinium bromide and vilanterol for the first time in the case that long-acting inhaled anticholinergic and long-acting inhaled beta2-agonist combination is required. ANORO and ELLIPTA is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse drug reactions
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: umeclidinium bromide and vilanterol
Enrollment:
2000
Observational study model:
Case-Only
Primary completion date:
2019-03-07
Time perspective:
Prospective
Clinical publications:
Otake R, Yoshimoto D, Oda K, Sakata K, Kaneuchi A, Ishi T, Hara T. Assessment of the Safety and Efficacy of Umeclidinium Bromide/Vilanterol Trifenatate Dry Powder Inhaler for Chronic Obstructive Pulmonary Disease (COPD) - Final report of drug use investigation. Prog Med. 2020;40(3):287-301
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
February 2015 to July 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subjects with chronic obstructive pulmonary disease (COPD)
- Subjects who are treated with umeclidinium bromide and vilanterol for the first time
- none
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with chronic obstructive pulmonary disease (COPD)
- Subjects who are treated with umeclidinium bromide and vilanterol for the first time
Exclusion criteria:
- none
Trial location(s)
No location data available.
Study documents
Clinical study report
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
Finalized
Actual primary completion date
2019-03-07
Actual study completion date
2019-03-07
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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