Last updated: 11/07/2018 12:25:53
Meta-Analysis Plan for an analysis to compare the efficacy of Umeclidinium/Vilanterol Inhalation Powder 62.5/25 mcg with tiotropium 18mcg in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Meta-Analysis Plan for an analysis to compare the efficacy of Umeclidinium/Vilanterol Inhalation Powder 62.5/25 mcg with tiotropium 18mcg in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose is to conduct a post hoc meta-analysis of data from studies ZEP117115, DB2113360 and DB2113374 to compare the efficacy of UMEC/VI 62.5/25 mcg with TIO 18 mcg in subjects with COPD.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Trough forced expiratory volume in 1 second (FEV1) at Days 2, 28, 56, 84, 112, 168 and 169
Timeframe: Days 2, 28, 56, 84, 112, 168 and 169
Proportion of subjects achieving an increase of >=100 milliliters (mL) above Baseline in trough FEV1 at Days 2, 28, 56, 84, 112, 168 and 169
Timeframe: Baseline, Days 2, 28, 56, 84, 112, 168 and 169
Change from Baseline in rescue-free days over the entire 24-week period
Timeframe: Baseline and Week 1 to Week 24
Number of puffs/day of rescue medication over the entire 24-week period
Timeframe: Week 1 to Week 24
Proportion of subjects achieving a change from baseline in percentage of rescue free days over the entire 24 week period of >=(100/12), representing approximately one extra month of rescue-free days over a year
Timeframe: 24 Weeks
St. George’s Respiratory Questionnaire (SGRQ) score at Days 28, 84 and 168
Timeframe: Days 28, 84 and 168
Proportion of subjects achieving a decrease of >=4 units below Baseline in SGRQ at Days 28, 84 and 168
Timeframe: Baseline, and Days 28, 84 and 168
Secondary outcomes:
Not applicable
Interventions:
Drug: UMEC 125 mcg
Drug: Albuterol/salbutamol
Drug: VI 25 mcg
Device: Novel DPI
Drug: UMEC/VI 125/25 mcg
Drug: TIO 18 mcg
Drug: Ipratropium bromide
Drug: UMEC/VI 62.5/25 mcg
Device: HandiHaler
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017;33(12):2188-2199.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
tiotropium bromide, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
None
Study date(s)
October 2014 to November 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subjects from the studies DB2113374, ZEP117115, and DB2113360 who were included in ITT population.
- Subjects from study DB2113360 who were enrolled at Investigator Site 040688.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects from the studies DB2113374, ZEP117115, and DB2113360 who were included in ITT population.
Exclusion criteria:
- Subjects from study DB2113360 who were enrolled at Investigator Site 040688.
Trial location(s)
No location data available.
Study documents
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
Not applicable
Actual study completion date
2014-03-11
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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