Last updated: 02/04/2020 18:30:06

Systematic Review and Meta-Analysis of the Impact of Alternative Treatments on Mortality Outcomes in Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
114043
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: Systematic Review and Meta-Analysis of the Impact of Alternative Treatments on Mortality Outcomes in Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The study primary objective is to estimate the impact of alternative drug treatments on mortality in COPD patients by using network meta-analysis to synthesise randomised controlled trials (RCTs) data. Exploratory sensitivity analyses are conducted to test the robustness of the results. The analysis will produce estimates of the relative efficacy of each drug treatment with respect to the all-cause mortality endpoint and the uncertainty around these estimates. The study will comprise a systematic review and network meta-analysis. The systematic review will identify blinded randomised controlled trials of COPD medications compared to placebo. Studies will be required to report all-cause mortality data, for 24 or more weeks of follow-up, in binary or hazard ratio form.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

All cause mortality in both Intention to Treat (ITT) and On Treatment (OT) populations

Timeframe: 24 weeks or more

Secondary outcomes:

Inclusion of on-treatment mortality results in preference to ITT results, where available

Timeframe: 24 weeks or more

Excluding studies where patients have high lung function at baseline (mean FEV1 %predicted >65%)

Timeframe: 24 weeks or more

Analysing tiotropium study arms by inhaler (mist inhaler and dry powder inhaler) and including results of the TIOSPIR study (Wise et al. 2013)

Timeframe: 24 weeks or more

Excluding studies not meeting specified quality assessment criteria

Timeframe: 24 weeks or more

Excluding studies not powered for mortality

Timeframe: 24 weeks or more

Excluding studies less than 48 weeks duration

Timeframe: 48 weeks or more

Including studies with unpublished mortality data from recent network meta-analysis (Dong et al 2013)

Timeframe: 24 weeks or more

Meta-regression on COPD severity

Timeframe: 24 weeks or more

Excluding studies where patients were administered unlicensed doses

Timeframe: 24 weeks or more

Interventions:
  • Drug: formoterol
  • Drug: budesonide
  • Drug: ipratropium bromide
  • Drug: fluticasone propionate
  • Drug: indacaterol
  • Drug: roflumilast
  • Drug: salbutamol
  • Drug: salmeterol
  • Drug: fluticasone furoate
  • Drug: beclomethasone
  • Drug: tiotropium
  • Drug: indacaterol maleate
  • Drug: triamcinolone
  • Drug: theophylline
  • Drug: vilanterol trifenatate
  • Drug: bambuterol
  • Drug: placebo
    • Enrollment:
    0
    Primary completion date:
    2013-02-10
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    David A Scott, Bethan Woods, Juliette C Thompson, James F Clark, Neil Hawkins, Mike Chambers, Bartolome R. Celli ,Peter Calverley. Mortality and drug therapy in patients with chronic obstructive pulmonary disease: a network meta-analysis. BMC Pulm Med.2015;15:145.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate/salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2013 to October 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Inclusion and exclusion criteria for source studies
    • Abstracts will be reviewed against the following inclusion and exclusion criteria:
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion and exclusion criteria for source studies Abstracts will be reviewed against the following inclusion and exclusion criteria:

      • Target population: Subjects with a diagnosis of COPD (any severity).
      • Methodological criteria: blinded randomised controlled trials that followed patients for 24 weeks or more post-randomisation. Trials reporting a cross-over design will be included if the period before cross-over is at least 24 weeks.
      • Intervention: Trials comparing two or more of the pharmacological interventions listed above administered at any dose or comparing one or more with placebo. Trials comparing different doses of the same drug cannot be included unless another comparator on the list is incorporated into that trial. Trials reporting combination treatments including drugs not on the list were not included unless at least two arms of the trial met the inclusion criteria.
      • Reporting criteria: Trials for which the full study report or publication is available. Trials reporting number of subjects randomised to each arm. Publications solely in the English language will be included. Exclusions: Secondary publications will be excluded unless additional data relevant to the present analysis is presented in these publications. Conference abstracts will not be included.

    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
    2013-02-10
    Actual study completion date
    2013-02-10

    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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