Last updated: 02/04/2020 16:00:22
Evidence synthesis to assess comparative efficacy of UMEC/VI versus other treatments for COPD adult patientsUMEC/VI ITC
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Evidence synthesis to assess comparative efficacy of UMEC/VI versus other treatments for COPD adult patients
Trial description: The objective of this study was to assess the comparative efficacy of UMEC/VI compared with open dual (indacaterol + tiotropium), open triple (Salmeterol + fulticasone propionate fixed dose combination + tiotropium) and QVA (indacaterol + glycopyrronium). 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, 24 and 52 weeks
Secondary outcomes:
change from baseline for SGRQ total score
Timeframe: 12 and 24 weeks
mean number of puffs per day
Timeframe: 24 and 52 weeks
change from baseline for TDI focal score
Timeframe: 12 and 24 weeks
Interventions:
Drug: tiotropium
Drug: SFC
Drug: QVA
Drug: UMEC/VI
Drug: indacaterol
Enrollment:
0
Observational study model:
Other
Primary completion date:
2014-13-06
Time perspective:
Other
Clinical publications:
Huisman EL, Cockle SM, Ismaila AS, Karabis A, Punekar YS. Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015;10(1):1863-1881.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
MAPI
Study date(s)
September 2013 to June 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35+ years
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
Scientific result summary
Available language(s): English
Protocol
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
2014-13-06
Actual study completion date
2014-13-06
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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