Last updated: 12/02/2024 07:00:16
Meta-Analysis Plan for 209652: A Meta-Analysis to Evaluate the Effect of Active Interventions vs Placebo or Usual Care on the Rate of Decline in FEV1 in participants with Chronic Obstructive Pulmonary Disease (COPD)
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 Plan for 209652: A Meta-Analysis to Evaluate the Effect of Active Interventions vs Placebo or Usual Care on the Rate of Decline in FEV1 in participants with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this meta-analysis is to evaluate the overall effect of interventions (including medications and smoking cessation) versus placebo/usual care on the rate of decline in FEV1 in COPD subjects. The studies included in the meta-analysis were selected by literature search followed by clinical review.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of decline in post-bronchodilator FEV1 (milliliter [mL]/year)
Timeframe: Up to 4 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-08-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Bartolome R Celli, Julie A Anderson, Nicholas J Cowans, Courtney Crim, Benjamin F Hartley, Fernando J Martinez, Andrea Morris, Holly Quasny, Julie Yates, Jørgen Vestbo, Peter MA Calverley. Pharmacotherapy and Lung Function Decline in Patients with Chronic Obstructive Pulmonary Disease: A Systematic Review. Am J Respir Crit Care Med. 2020;
DOI: 10.1164/rccm.202005-1854OC
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2018 to July 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
Not applicable
- Published randomized controlled trials in which COPD subjects were randomized to an active treatment/therapy or placebo/usual care and followed up for at least 2 years.
Inclusion and exclusion criteria
Inclusion criteria:
- Published randomized controlled trials in which COPD subjects were randomized to an active treatment/therapy or placebo/usual care and followed up for at least 2 years.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
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
2019-08-07
Actual study completion date
2019-08-07
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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