Last updated: 07/31/2020 01:20:22
Meta Analysis of Dual Bronchodilators Impact of Lung Function Benefit vs. Spiriva
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta Analysis of Dual Bronchodilators Impact of Lung Function Benefit vs. Spiriva
Trial description: The dual bronchodilator therapy is used in treatment of Chronic Obstructive Pulmonary Disease (COPD). The aim of this retrospective study is to assess the relative efficacy of United States (US) -approved dosages of Long-acting Muscarinic Agent/ Long-acting Beta-agonist Bronchodilators (LAMA/LABA) versus Tiotropium (TIO) for COPD. The study will describe indirect treatment comparison by capturing all evidence to date of LABA/LAMA vs. TIO for US-approved dosages and will use the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines to identify published, randomized controlled clinical trials (RCTs) comparing selected therapies in subjects with COPD. RCTs of a minimum duration of 8 weeks comparing LABA/LAMA to TIO in adult COPD subjects will be included.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in trough Forced Expiratory Volume in One Second (FEV1) at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in Peak FEV1 at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in Area Under Curve (AUC) at Week 24
Timeframe: Baseline and Week 24
Secondary outcomes:
Change from Baseline in trough FEV1 at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in Peak FEV1 at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in AUC at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) total score at Week 12 and Week 24
Timeframe: Baseline and up to Week 24
SGRQ responder rate at Week 12 and Week 24
Timeframe: Up to Week 24
Change from Baseline in number of puffs of rescue medication used per day at Week 12 and Week 24
Timeframe: Baseline and up to Week 24
Number of subjects with any adverse events (AE) and any serious adverse events (SAE)
Timeframe: Up to Week 24
Interventions:
Enrollment:
1
Primary completion date:
2017-13-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Han M, Ray R, Foo J, Morel C, Hahn B. Systematic literature review and meta-analysis of US-approved LAMA/LABA therapies versus tiotropium in moderate-to-severe COPD. npj Prim Care Respir J. 2018;28(32)
DOI: 10.1038/s41533-018-0099-1
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
February 2017 to April 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Subject characteristics: Subjects with COPD as defined by Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines; studies that include asthma subjects and COPD subjects and report data for COPD subjects separately; Adults; Studies that include adults and children and report data for adults separately; Subgroup data for moderate and severe COPD also of interest.
- Intervention: US approved dosage of LABA/LAMA combinations including Umeclidinium/Vilanterol 62.5/25 micrograms (mcg), Olodaterol/TIO 5/5 mcg, Glycopyrrolate/formoterol 18/9.6 mcg, Glycopyrronium /indacaterol 15.6/27.5 mcg.
- Subject population: Studies with only healthy subjects without COPD; Studies with subjects who have reversible airway or obstructive lung disease; Studies with only subjects with asthma; Studies that include asthma subjects and COPD subjects but do not report data for COPD subjects separately; Studies with only subjects who have alpha-1-antitrypsin-definciency-realted COPD; Studies that include only children; Studies that include adults and children but do not report data for adults separately;
- Intervention: Beta- agonists (Bambuterol; Fonoterol; Tulobuterol); Short-acting anticholinergics (Ipratropium; Oxitropium); Methylxanthines (Theophylline); Leukotriene receptor antagonists (montelukast); COPD drugs in development or targeting other pathways (roflumilast; polyvalent mechanical bacterial lysate; lipopolysaccharide); All other pharmaceutical interventions not treating COPD (enoxaparin sodium); Non-pharmaceutical interventions such as pulmonary rehabilitation.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject characteristics: Subjects with COPD as defined by Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines; studies that include asthma subjects and COPD subjects and report data for COPD subjects separately; Adults; Studies that include adults and children and report data for adults separately; Subgroup data for moderate and severe COPD also of interest.
- Intervention: US approved dosage of LABA/LAMA combinations including Umeclidinium/Vilanterol 62.5/25 micrograms (mcg), Olodaterol/TIO 5/5 mcg, Glycopyrrolate/formoterol 18/9.6 mcg, Glycopyrronium /indacaterol 15.6/27.5 mcg.
- Comparator: Studies that compare treatments of interest to each other or to TIO 5 mcg or 18 mcg.
- Outcomes: Studies that Report results for at least one of the following outcomes for all treatments: Change from Baseline in Trough FEV1; Peak FEV1; AUC FEV1; SGRQ score; Rescue medication, response rate of SGRQ score, number of subjects with AE and serious AE. Outcomes should be reported at 8-16 weeks or 20-28 weeks. Subgroup data for moderate and severe COPD also of interest
- Study design: Randomized controlled trials.
Exclusion criteria:
- Subject population: Studies with only healthy subjects without COPD; Studies with subjects who have reversible airway or obstructive lung disease; Studies with only subjects with asthma; Studies that include asthma subjects and COPD subjects but do not report data for COPD subjects separately; Studies with only subjects who have alpha-1-antitrypsin-definciency-realted COPD; Studies that include only children; Studies that include adults and children but do not report data for adults separately;
- Intervention: Beta- agonists (Bambuterol; Fonoterol; Tulobuterol); Short-acting anticholinergics (Ipratropium; Oxitropium); Methylxanthines (Theophylline); Leukotriene receptor antagonists (montelukast); COPD drugs in development or targeting other pathways (roflumilast; polyvalent mechanical bacterial lysate; lipopolysaccharide); All other pharmaceutical interventions not treating COPD (enoxaparin sodium); Non-pharmaceutical interventions such as pulmonary rehabilitation.
- Comparator: Studies that only compare treatments that are not of interest; Studies that only include the treatments of interest in combination with treatments not of interest (i.e. prednisolone + formoterol); Studies that only include the partial combinations of treatments of interest (i.e. tiotropium+ Inhaled corticosteroid).
- Outcomes: None of the relevant outcomes is reported; Only report the following outcomes (without any outcomes of interest): Mortality; Bioactivity outcomes or biomarkers of inflammation; Lung mucociliary clearance; Arterial blood gases or degree of pulmonary hyper-inflation; Plethysmography and oscillometry; Nocturnal hypoxemia; Quality of life in European Quality of Life (EuroQol); Outcomes reported at other time points.
- Study design: Cross-over studies, if cross over before 8 weeks in each arm; Post-hoc or retrospective analyses; Cost-effectiveness analyses; Observational studies; Reviews or meta-analyses; Methodology studies or protocols; number of 1 trials (sample size of 1 subject); Studies lasting less than 8 weeks; Conference abstracts before 2009; Studies not in the English language; Studies where subjects were required to spend time in a sleep laboratory.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
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
Study complete
Actual primary completion date
2017-13-04
Actual study completion date
2017-13-04
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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