Last updated: 02/04/2020 16:00:09

Evidence synthesis to assess comparative efficacy of UMEC versus other treatments for COPD adult patientsUMEC ITC

GSK study ID
201280
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evidence synthesis to assess comparative efficacy of UMEC versus other treatments for COPD adult patients
Trial description: The objective of this study was to assess the comparative efficacy of UMEC compared with other Long Acting Muscarinic Antagonists (LAMAs) which include tiotropium (TIO), glycopyrronium (GLY) and aclidinium (ACL). The outcomes of interest were
forced expiratory volume (FEV1), St. Georges Respiratory Questionnaire (SGRQ), transition dyspnoea index (TDI) and rescue medication use at all available time points. The study will involve a systematic literature review to identify all published evidence on the comparators followed by indirect treatment comparison using a frequentist and/or bayesian approach.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

change from baseline for trough FEV1

Timeframe: 12 and 24 weeks

Secondary outcomes:

change from baseline for SGRQ total score

Timeframe: 12 and 24 weeks

change from baseline for TDI focal score

Timeframe: 12 and 24 weeks

mean number of puffs per day

Timeframe: 12 and 24 weeks

Interventions:
Drug: GLY
Drug: ACL
Drug: UMEC
Drug: TIO
Enrollment:
0
Observational study model:
Other
Primary completion date:
2015-06-03
Time perspective:
Other
Clinical publications:
Ismaila AS, Huisman EL, Punekar YS, Karabis A. Comparative efficacy of long-acting muscarinic antagonist monotherapies in COPD: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015;16(10):2495-517.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
MAPI
Study date(s)
January 2014 to March 2015
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
35 - 100 Year
Accepts healthy volunteers
none
  • COPD patients
  • 35 years of any race and gender
Inclusion and exclusion criteria
Inclusion criteria:
  • COPD patients
  • 35 years of any race and gender
  • eligible to receive COPD maintenance therapy

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
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
Finalized
Actual primary completion date
2015-06-03
Actual study completion date
2015-06-03

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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