COPD Exercise Endurance Study (DB2114417)

• Research type

  Research Study

• Full title

  An exercise endurance study to evaluate the effects of treatment of COPD patients with a dual bronchodilator: GSK573719/GW642444.

• IRAS ID

  78881

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2010-023442-75

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to test the effect of a new drug combination in patients with a lung disease called Chronic Obstructive Pulmonary Disease (COPD). Symptoms of COPD include chronic cough and severe shortness of breath. Common medicines used in treating COPD include drugs called bronchodilators that help open and relax muscles in the airways. Some have been shown to improve breathlessness and exercise endurance.The new drug being studied is a combination of two inhaled bronchodilators (GSK573719 and GW642444). These are not currently approved for doctors to prescribe to patients. The study will investigate the effects of this drug combination in patients aged over 40 who have COPD, in particular looking at patients?? lung function and exercise endurance.The study will test the drugs at different doses, both in combination and on their own. Participants in the study will not know which treatment group they are in, but each participant will receive one treatment for the first part of the study, and then be changed to another treatment for the second part. Some participants will receive a dummy drug for one part of the study. A computer will put people into groups by chance.Participants will be asked to attend 12 clinic visits during the study, spread over about 30 weeks. Some of the visits may last several hours. During these visits, participants will be asked to undergo a number of tests, including tests of their lung function, blood tests, and two different walking tests of how far and how fast they can walk. Participants will also be asked to keep a diary during the study to record medicines they take and any medical problems they may be having.The study is being funded by GlaxoSmithKline and will take place at several hospitals in the UK.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0125

• Date of REC Opinion

  15 Jun 2011

• REC opinion

  Further Information Favourable Opinion