Bioequivalence study of Budesonide/formoterol Easyhaler and Symbicort

• Research type

  Research Study

• Full title

  Bioequivalence study comparing two budesonide/formoterol fumarate dihydrate device-metered dry powder inhalers, Budesonide/formoterol Easyhaler 200/6 µg/inhalation and Symbicort Turbohaler 200 µg/6µg/inhalation; a randomised, double-blind, double-dummy, single centre, single dose, crossover study in asthmatic patients

• IRAS ID

  25533

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Eudract number

  2009-011956-24

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The study drug under investigation on this study is Budesonide/formoterol Easyhaler© which is a device-metered dry powder inhaler (dmDPI) containing the combination of budesonide (inhaled steroid) and formoterol fumarate dihydrate (long-acting airway opener). This combination product is being developed for treatment of asthma and the aim of the study is to compare it with a marketed product Symbicort Turbohaler in terms of the amount of drug absorbed into the bloodstream. Both the Budesonide/formoterol Easyhaler and Symbicort Turbohaler contain Budesonide and Formoterol. The combination of these drugs gives optimal control of asthma in patients not adequately controlled with corticosteroid and short-acting airway opener. When drugs are inhaled some of the drug will be absorbed into the lungs but a proportion of it will be swallowed. For this study, in order to accurately assess how much drug is deposited in the lungs we need to block the absorption of the drug from the stomach into the blood stream. To enable this on two of the treatment days subjects will be given a charcoal drink before and immediately after taking the study medication and again at 45 mins and 1hr 30mins afterwards. On the other 2 treatment days subjects will be given the medication without the charcoal drink. The study involves 56 participants and will consist of a screening period (maximum of 3 weeks) and 4 treatment periods separated by a 3-21 days wash-out period (the randomisation schedule is documented in the protocol) and a follow-up visit up to 7 days after the final treatment.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/41

• Date of REC Opinion

  17 Aug 2009

• REC opinion

  Further Information Favourable Opinion