Last updated: 11/07/2018 12:03:29

Meta-analysis of DB2116132 and DB2116133. An integrated review to evaluate dose reponse of GSK573719 administered once daily in subjects with COPD

GSK study ID
201233
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: Meta-analysis of DB2116132 and DB2116133. An integrated review to evaluate dose reponse of GSK573719 administered once daily in subjects with COPD
Trial description: The primary objective of this meta-analysis of both responder studies (DB2116132/DB2116133) is to further evaluate the lung function response following treatment with UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg administered once-daily via the Novel Dry Powder Inhaler (NDPI) in subjects with COPD. The efficacy endpoint of interest is the weighted mean FEV1 over 0-6 hours post-dose on Day 14 of each treatment period.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The efficacy endpoint of interest is the weighted mean FEV1 over 0-6 hours post-dose

Timeframe: Day 14 of each treatment period.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: UMEC/VI 62.5/25mcg; UMEC 62.5mcg; VI 25mcg
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Donohue JF, Singh D, Munzu C, Kilbride S, Church A. Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: results from two randomised controlled trials. Respir Med. 2016;112:65-74.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    December 2013 to April 2014
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    none
    • N/A
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • N/A
    Exclusion criteria:
    • N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    Not applicable
    Actual study completion date
    2014-07-04

    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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