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

GSK study ID
200167
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: 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
    Primary completion date:
    2014-13-06
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    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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