PD effects of Budesonide/Formoterol Spiromax Powder and Symbicort®

• Research type

  Research Study

• Full title

  A randomized, double-blind, double-dummy, cumulative-dose, four-period crossover study to evaluate the phamacodynamic effects of Budesonide/Formoterol Spiromax® Inhalation Powder and Symbicort® Turbohaler® administered in healthy volunteers

• IRAS ID

  62393

• Contact name

  Muna Albayaty

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2010-021655-64

• 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 acomparable drug (Symbicort©) on the market have similar responses to exposure and adverse events. In this study, the pharmacodynamic (extrapulmonary) effects and safety of Budesonide/Formoterol Spiromax© and Symbicort© will be investigated after cumulative doses. The study will be performed in different parts and approximately 52 healthy male and female participants will be enrolled. Certain criteria will be applied in order to reach valid conclusions for the study objectives. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. The study medication will be administered to the participants as an oral inhalation powder. Participants will attend training over two consecutive days on the use of administration devices. Participants will receive four cummulative administrations sets (1ퟭ) (alternating between both study medications in each set), in each of four treatment periods. Participants will undergo the following procedures during the study: medical and medication history; physical examination; height and weight; vital signs (blood pressure, pulse rate and temperature); urine and blood safety tests; serial pharmacodynamic assessments (ECG, vital signs, plasma glucose and potassium). 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/IEC01/21

• Date of REC Opinion

  23 Sep 2010

• REC opinion

  Further Information Favourable Opinion