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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/48226
• EU PAS number:
  EUPAS21362
• Study ID:
  48226
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a meta-analysis. The purpose of this meta-analysis is to evaluate the most important risk factors, alone and in combination for pneumonia and chronic obstructive pulmonary disease (COPD) exacerbations in patients with COPD. The analysis will identify the subgroups of COPD patients which are most at risk for these events and quantify the probability of patients having those events.
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 03/07/2017

Study start date

Actual: 03/07/2017

Date of final study report

Planned: 18/09/2018

Actual: 06/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-207941-reporting-and-analysis-plan-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only