Efficacy and Safety of Budesonide delivered by VR475 Inhalation System

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of nebulised budesonide delivered by the VR475 Inhalation System, with an open-label comparison to conventionally nebulised budesonide, in patients with uncontrolled asthma despite treatment with high dose inhaled corticosteroid and at least a second controller (GINA Step 4) and those receiving oral corticosteroid (GINA Step 5)

• IRAS ID

  184678

• Contact name

  Timothy Harrison

• Sponsor organisation

  Vectura Limited

• Eudract number

  2015-000353-20

• Duration of Study in the UK

  2 years, 1 months, 31 days

• Research summary

  Inhaled corticosteroid treatments are regarded as effective medications for the treatment of chronic asthma. They work by reducing asthma symptoms, improving quality of life, improving the function of the lungs, and reducing the number and severity of asthma attacks a person experiences.

  Budesonide is an inhaled corticosteroid which has been prescribed for children and adults with persistent asthma since 1983. Vectura Limited (the Sponsor) has developed a new type of nebuliser device for use in the treatment of uncontrolled asthma in adult and adolescent patients.

  A new nebuliser has been designed to deliver the well-known drug, budesonide. It is different from other nebulisers in that the compressor is controlled by an integrated, removable, smart card (the VR475 Smart Card), which controls the length and the number of inhalations.

  The main purpose of this study is to find out if budesonide, given twice daily in a range of doses via the new nebuliser for approximately 52 weeks, when compared to budesonide administered using an already approved nebuliser, is an effective and safe treatment for uncontrolled asthma.

  The safety and effectiveness of the use of budesonide in combination with the new nebuliser are being investigated in this study (i.e. the use of budesonide and the new nebuliser device together is not currently approved to treat uncontrolled asthma by the European Medicines Agency (EMA) or any other local regulatory agency).

  Participants will have around 16 visits to the study clinic and the treatment period will include lung function tests, blood samples, an ECG, study questionnaires, examination of eyes, skin, and vocal cords as well as urine samples for women who are able to become pregnant.

  The study is expected to treat approximately 474 patients with uncontrolled asthma and will be conducted at approximately 120 centres in about 12 countries.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  15/EM/0309

• Date of REC Opinion

  28 Sep 2015

• REC opinion

  Further Information Favourable Opinion