Last updated: 11/07/2018 12:52:53

Meta-Analysis Plan for an analysis to compare the efficacy and safety of UMEC/VI 62.5/25mcg versus Placebo, UMEC/VI 62.5/25mcg versus TIO 18mcg and UMEC/VI 62.5/25mcg versus FSC 250/50 in elderly subjects with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
208125
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: Meta-Analysis Plan for an analysis to compare the efficacy and safety of UMEC/VI 62.5/25mcg versus Placebo, UMEC/VI 62.5/25mcg versus TIO 18mcg and UMEC/VI 62.5/25mcg versus FSC 250/50 in elderly subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this meta-analysis is to compare the efficacy and safety of UMEC /VI 62.5/25 mcg with Placebo, TIO 18 mcg and FSC 250/50 mcg Combination Product in COPD elderly subjects included in the following seven parallel design studies: DB2113360, DB2113373, DB2113374, DB2114930, DB2114951, MID201211 and ZEP117115 and three cross over studies: DB2114417, DB2114418 and MID201317. The studies DB2113360, DB2113373, DB2113374, DB2114930, DB2114951, MID201211 and ZEP117115 will be included in parallel group 12-week integration analysis. The studies DB2113360, DB2113373, DB2113374 and ZEP117115 will be used in parallel group 24-week integration analysis. The studies DB2114930, DB2114951 and MID201211 have a duration of 12 weeks and will be excluded from the parallel group 24 week integration analysis. The studies DB2114417, DB2114418 and MID201317 will be included in the crossover 12-week integration analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Trough forced expiratory volume in 1 second (FEV1)

Timeframe: Up to Day 169

Percentage of subjects with an increase of >= 100 milliliter (mL) above baseline in trough FEV1

Timeframe: Up to Day 169

Number of subjects with Adverse Events (AE) and Serious AE (SAE)

Timeframe: Up to Week 24

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
8800
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ray R, Tombs L, Asmus M, Boucot I, Lipson D, Compton C, Naya I. Efficacy of Umeclidinium/Vilanterol in elderly patients with COPD: a pooled analysis. Drugs Aging. 2018;35(7):637-647.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, tiotropium bromide, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
August 2017 to October 2017
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
None
  • All studies conducted with UMEC/VI 62.5/25 mcg with a Placebo, TIO 18 mcg or FSC 250/50 of at least 12 weeks duration.
  • DB2113360, DB2113373, DB2113374, DB2114930, DB2114951, MID201211 and ZEP117115 studies will be included in parallel group 12-week integration analysis.
  • The studies DB2114930, DB2114951 and MID201211 have a duration of 12 weeks and will be excluded from the parallel group 24 week integration analysis.
Inclusion and exclusion criteria
Inclusion criteria:
  • All studies conducted with UMEC/VI 62.5/25 mcg with a Placebo, TIO 18 mcg or FSC 250/50 of at least 12 weeks duration.
  • DB2113360, DB2113373, DB2113374, DB2114930, DB2114951, MID201211 and ZEP117115 studies will be included in parallel group 12-week integration analysis.
  • DB2113360, DB2113373, DB2113374 and ZEP117115 studies will be used in parallel group 24-week integration analysis.
  • DB2114417, DB2114418 and MID201317 studies will be included in the crossover 12-week integration analysis.
Exclusion criteria:
  • The studies DB2114930, DB2114951 and MID201211 have a duration of 12 weeks and will be excluded from the parallel group 24 week integration analysis.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

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
Not applicable
Actual study completion date
2017-05-10

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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