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)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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Including studies with unpublished mortality data from recent network meta-analysis (Dong et al 2013)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
Observational study model:
Other
Primary completion date:
2013-02-10
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:
- 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.
Inclusion and exclusion criteria for source studies Abstracts will be reviewed against the following inclusion and exclusion criteria:
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
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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