Comparison of two asthma formulations in healthy volunteers

• Research type

  Research Study

• Full title

  An open-label, randomized, five-period crossover, single-dose study to compare the pharmacokinetic profiles following two inhalations of Budesonide/Formoterol Spiromax® 160/4.5 mcg Inhalation Powder and Symbicort® Turbohaler® 200/6 mcg, with and without charcoal block, administered in healthy volunteers

• IRAS ID

  54820

• Contact name

  Muna Albayaty

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2009-014498-42

• Research summary

  Asthma is a chronic disorder in which the lung's airways become inflamed and breathing becomes difficult. Previous human studies show that the drug under investigation (Budesonide/Formoterol Spiromax© inhalation powder) and a comparable drug (Symbicort©) on the market have similar responses to exposure and adverse events. In this study, the pharmacokinetic profiles of single doses of Budesonide/Formoterol Spiromax© and Symbicort© will be investigated. The study will be performed in different parts and approximately 90 healthy male and female participants will be enrolled. Certain criteria will be applied in order to reach valid conclusions for the study objective. ThestudywillbeperformedatthePAREXELEarlyPhaseClinicalUnit,NorthwickPark Hospital,Harrow. Thestudymedicationwillbeadministeredtotheparticipant'sanoralinhalation powder. In some parts of the study, participantswillhavetodrinkasuspensionofcharcoalbeforeandafterstudymedicationinhalation. Participantswillreceivesevensingleadministrations(oftwooralinhalations)of thestudymedication, twointhetrainingperiodandoneineachofthefive treatmentperiods. Participantswillundergothefollowingproceduresduringthestudy:medicaland medicationhistory;physicalexamination; heightandweight;electrocardiogram(ECG);vitalsigns(bloodpressure,pulserateandtemperature); urineandblood safety tests;andbloodsamplesforthemeasurementofstudydrugconcentration.Any adverse events that participants experience and other medication that they take will be recorded.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/20

• Date of REC Opinion

  27 Aug 2010

• REC opinion

  Further Information Favourable Opinion