Last updated: 03/08/2019 21:20:08

Meta-Analysis Plan for 209304 (DB2113361 and DB2113373): Phase III Efficacy and Safety Studies of GSK573719 (umeclidinium)/GW642444 (vilanterol) Inhalation Powder Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease

GSK study ID
209304
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta-Analysis Plan for 209304 (DB2113361 and DB2113373): Phase III Efficacy and Safety Studies of GSK573719 (umeclidinium)/GW642444 (vilanterol) Inhalation Powder Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease
Trial description: This meta-analysis study will use data from studies DB2113361 and DB2113373 to compare the efficacy and safety of UMEC/VI 62.5/25 micrograms (µg) and 125/25 mcg, UMEC 62.5 µg and 125 µg, VI 25 mcg and placebo when administered once-daily via novel dry powder inhaler (NDPI) by subjects with Chronic Obstructive Pulmonary Disease (COPD). DB2113361 and DB2113373 were randomized, double-blinded, parallel group studies with 24-week treatment period. The evaluation of efficacy and safety will be done along with various levels of concomitant medications.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in Trough forced expiratory volume in one second (FEV1)

Timeframe: Baseline and up to Day 169

Time to first COPD exacerbation

Timeframe: Up to Day 169

Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ)

Timeframe: Baseline and up to Day 168

Change from Baseline in Transitional Dyspnea Index (TDI) focal score

Timeframe: Baseline and up to Day 168

Number of subjects with adverse events (AE) and serious adverse events (SAE) and adverse events leading to discontinuation (AELDs)

Timeframe: Up to Week 24

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-01-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2018 to September 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
  • COPD subjects who received UMEC/VI 62.5/25 mcg or UMEC/VI 115/25mcg, UMEC 62.5mcg or UMEC 115mcg, VI 25 mcg or placebo over a treatment period of 24 weeks in DB2113373 and DB2113361, which were randomized, multicenter, double-blind, double dummy, parallel group studies, will be included in this meta-analysis.
Inclusion and exclusion criteria
Inclusion criteria:
  • COPD subjects who received UMEC/VI 62.5/25 mcg or UMEC/VI 115/25mcg, UMEC 62.5mcg or UMEC 115mcg, VI 25 mcg or placebo over a treatment period of 24 weeks in DB2113373 and DB2113361, which were randomized, multicenter, double-blind, double dummy, parallel group studies, will be included in this meta-analysis.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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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