Efficacy and safety of Fluticasone Furoate/GW642444 in COPD

• Research type

  Research Study

• Full title

  HZC102970: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

• IRAS ID

  29503

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-013064-40

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to look at the effect of a new drug on patients with a lung disease called Chronic Obstructive Pulmonary Disease (COPD). The most common medicines used for the treatment of COPD are drugs called inhaled corticosteroids that help reduce inflammation (swelling and redness) in the lungs and drugs called bronchodilators that help open up and relax muscles in the airways.The new drug being studied is a combination ofluicasone furoate (FF) (an inhaled corticosteroid) and GW642444 (a bronchodilator). FF/GW642444 is currently not approved for doctors to prescribe to patients. It is being studied in people with COPD and asthma.This study will look at the effects, both good and bad, of this new drug in patients aged over 40 who have COPD. This study will compare three different doses of study drug to one dose of the beta agonist alone. Three groups of people will take different strengths of FF/ GW642444 and another group will take GW642444 (the long acting beta agonist) alone. All patients will be given a combination ofluicasone propionate (another inhaled steroid) and Salmeterol (another bronchodilator) to use for the first 4 weeks of the study.The study Doctor and the people who take part won't know which group they are in. This way the findings from the groups will be handled in the same way. A computer will put people into groups by chance. Participants will have an equal chance of being placed in any of the groups.Information about how the study drug affects the participant's body and their health will be collected through a number of tests and procedures.The study will last about 57 weeks. During this time, participants will need to have tests, visit the clinic, and tell their study doctor about any changes.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/102

• Date of REC Opinion

  29 Sep 2009

• REC opinion

  Further Information Favourable Opinion