6-Month Safety and Benefit Study of SERETIDE in Children 4 - 11 Years

• Research type

  Research Study

• Full title

  A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 paediatric subjects 4-11 years old with persistent asthma

• IRAS ID

  88484

• Contact name

  Paul Seddon

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2011-001643-79

• ISRCTN Number

  n/a

• Research summary

  Asthma affects the airways ?? the tubes carrying air in and out of the lungs. People with asthma have sensitive airways which become irritated in some situations. The airways become narrow and sometimes produce more mucusflud that helps protect the airways) than usual. This makes it difficult to breathe. Asthma can??t be cured, but with the right treatment most people with asthma can lead normal lives. Inhaled corticosteroids (drugs similar to chemicals produced naturally by the human body) remain the main treatment for asthma and work by controlling its symptoms. A long-acting beta agonist is a medication that relaxes (opens/dilates) the airways to make breathing easier. SERETIDE is a medication that is a combination of an inhaled corticosteroid namefluicasone propionate together with a long-acting beta-agonist named salmeterol in a single inhaler. FLIXOTIDE is the medicatiofluicasone propionate by itself. GlaxoSmithKline is sponsoring a study to assess the safety and benefit of SERETIDE compared with FLIXOTIDE in the treatment of children aged 4 ?? 11 years old with persistent asthma. Study participants will receive study treatment and be followed for 6 months for their asthma status. This study is randomised and double-blind meaning that the treatment a patient will receive is allocated randomly, like tossing a coin, and neither the patient nor the study doctor will know whether the patient receives SERETIDE or FLIXOTIDE. The strength of the treatment that a patient will receive depends on how well their asthma is controlled as examined at the first study visit in the clinic. Four possible treatments are: ?½ SERETIDEfluicasone 100 micrograms and salmeterol 50 micrograms) ?½ SERETIDEfluicasone 250 micrograms / salmeterol 50 micrograms) ?½ FLIXOTIDEfluicasone 100 micrograms) ?½ FLIXOTIDEfluicasone 250 micrograms) About 6,200 children in approximately 50 countries around the world will take part in this study.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0035

• Date of REC Opinion

  15 May 2012

• REC opinion

  Further Information Favourable Opinion