Last updated: 11/24/2020 11:00:04
ENCRUSE ELLIPTA Drug Use Investigation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: ENCRUSE ELLIPTA Drug Use Investigation
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 to relief the symptoms of obstructive airway disorder and who are naive to the drug. ENCRUSE and ELLIPTA are 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
Enrollment:
1091
Observational study model:
Case-Only
Primary completion date:
2019-29-11
Time perspective:
Prospective
Clinical publications:
Sakata K, Yoshida M, Kaneuchi A, Ishii T, Hara T. Evaluation of Safety and Effectiveness of Umeclidinium Bromide Dry Powder Inhaler in Chronic Obstructive Pulmonary Disease (COPD) - Final Report of Drug Use Investigation -. Prog Med. 2020;40:1079-1091
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
April 2016 to November 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subjects with chronic obstructive pulmonary disease
- Subjects who are treated with umeclidinium bromide for the first time
- none
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with chronic obstructive pulmonary disease
- Subjects who are treated with umeclidinium bromide 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
2019-29-11
Actual study completion date
2019-29-11
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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