Last updated: 03/25/2019 18:40:09
Meta-Analysis plan for 209322: Influence of smoking status on the efficacy of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD in two Randomized, multi-center, double-blind, double dummy, parallel group studies (DB2114930 and DB2114951)
GSK study ID
209322
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Meta-Analysis plan for 209322: Influence of smoking status on the efficacy of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD in two Randomized, multi-center, double-blind, double dummy, parallel group studies (DB2114930 and DB2114951)
Trial description: The purpose of this meta-analysis is to understand if smoking status (current versus former smoker) has an influence on safety and efficacy of UMEC/VI 62.5/25 microgram (µg) once-daily (QD) versus FSC 250/50 µg twice-daily (BID) in subjects with chronic obstructive pulmonary disease (COPD) in studies DB2114930 and DB2114951. Both the studies were randomized, double-blind, double-dummy, parallel group studies to evaluate the efficacy and safety of UMEC/VI 62.5/25 µg QD when administered via Novel Dry Powder Inhaler (NDPI) compared with FSC 250/50 µg BID when administered via ACCUHALER®/DISKUS® inhaler over a treatment period of 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations. ACCUHALER and DISKUS are registered trademarks of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
24-hour weighted mean forced expiratory volume in 1 second (FEV1) on Day 84
Timeframe: Day 84
Trough FEV1 on Day 85
Timeframe: Day 85
Number of subjects achieving an increase of >=100 milliliters (mL) above Baseline in trough FEV1 on Days 28, 56, 84 and 85
Timeframe: Days 28, 56, 84 and 85
Serial FEV1 over 0 to 24 hours post-dose on Day 84
Timeframe: Day 84
Number of subjects with adverse events (AEs)
Timeframe: Up to Week 12
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-24-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
April 2018 to December 2018
Type
Observational
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
- COPD subjects who received UMEC/VI 62.5/25 µg QD or FSC 250/50 µg BID over a treatment period of 12 weeks in DB2114930 and DB2114951 which were randomized, multi-center, 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 µg QD or FSC 250/50 µg BID over a treatment period of 12 weeks in DB2114930 and DB2114951 which were randomized, multi-center, 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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