Meta-Analysis Plan for MID207941: A Study to Evaluate Risk Factors for Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in a COPD Population of Patients Treated with GW685698 + GW642444 (Fluticasone Furoate + Vilanterol); GW642444 (Vilanterol); CCI18781 (Fluticasone Propionate); GR33343 (Salmeterol); CCI18781+ GR33343 (Fluticasone Propionate + Salmeterol) and Placebo

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Name of medicine:
  Relvar
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients with COPD.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  10946

Study design details

• Main study objective:
  Evaluates the most important risk factors, alone and in combination for pneumonia and chronic obstructive pulmonary disease (COPD) exacerbations in patients with COPD. Expanding on known risks provided in RMP
• Outcomes:
  Time to first pneumoniaTime to first moderate/severe exacerbation
• Data analysis plan:
  Model estimated probability of eventHazard ratios for each covariate in the model

Documents

Study results

Additional information for 207941

gsk-207941-clinical-study-report-redact