PK profile of inhaled fluticasone propionate in healthy volunteers

• Research type

  Research Study

• Full title

  An open-label, randomized, four-period crossover, single-dose study to compare the pharmacokinetic profiles following two inhalations of Fluticasone ropionate HFA MDI 125 mcg and Flixotide Evohaler 125 mcg, with and without charcoal block, administered in healthy volunteers

• IRAS ID

  67650

• Contact name

  Muna Albayaty

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2010-022973-32

• Research summary

  Asthma is a chronic disease that affects the airways of the lungs, making them very sensitive to irritants. These cause the airways to narrow making it difficult to breathe. While there is no asthma cure, asthma can be controlled. There are many different asthma treatments, including fast acting ??rescue medications? for treating an asthma attack and longer acting ??controller medications? or ??preventer medications? used to prevent asthma attacks. <fluicasone propionate belongs to a group of medicines called corticosteroids (often just called steroids). It has an anti-inflammatory action and works by reducing swelling and irritation in the lungsfluicasone propionate is preventer medication which helps to prevent asthma attacks in people who need regular treatment. Participants will receive inhalations of the study drugfluicasone propionate HFA MDI) and a comparator drug (Flixotide Evohaler?½) already on the market. The study drug and the comparator drug contain the same medicinefluicasone propionate) in similar amounts, the main difference between the two being the device used to deliver the medicine.The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. Approximately 88 healthy, non-smoking males and females between the ages of 18 and 45 years will take part. The study drug and comparator drug will be administered to the participants as an oral inhalation powder, with and without charcoal block, in 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 and pulse rate); ECG; urine and blood safety tests; serial pharmacokinetic blood samples. Any adverse events that participants experience and other medication that they take will be recorded.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  10/IEC06/9

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion