Investigate the pharmacokinetics of a novel fluticasone inhaler

• Research type

  Research Study

• Full title

  A randomised phase I, open label, two-way crossover study to compare the pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of 250 mcg fluticasone propionate inhaled through a novel dry powder inhaler and Flovent® Diskus® in healthy subjects

• IRAS ID

  92391

• Contact name

  Leonard Siew

• Sponsor organisation

  Vectura Limited

• Eudract number

  2011-005362-38

• ISRCTN Number

  xx

• Research summary

  <fluicasone propionate has been available as a licensed inhaled medication on prescription for over 10 years in Europe and the US. It is used by many asthma sufferers all over the worldfluicasone propionate is a steroid. Inhaled steroids are the most effective anti-inflammatory medications for the treatment of persistent asthma. They are effective in a number of ways, which include reducing asthma symptoms and reducing the number of attacks (exacerbations) of asthma a patient may experience. Vectura Limited has developed a new dry powder inhaler for delivery ofluicasone propionate by inhalation. One of the dry powder inhalers fofluicasone propionate which is currently used in the United Kingdom and European Union is Flixotide©Accuhaler© (licensed and marketed for 14 years). The product has been licensed and marketed for eight years in the United States of America as Flovent©Diskus©. The drug powder delivered by inhalation into the lungs in the new inhaler is very similar to the approved powder form ofluicasone propionate available in the UK, (Flixotide©Accuhaler©) and the US, (Flovent©Diskus©), with slight differences in the amount delivered. The purpose of this study is to investigate if a new type of inhaler delivers a similar amount of a single dose of licensed inhaled steroidfluicasone propionate) to the lung as a licensed inhaler, by measuring the concentration of the drug in the blood stream. 40 healthy volunteers will be enrolled into the study. The total duration for participation in this study is approximately 7 weeks. It consists of 1 outpatient-screening visit followed by 2 admissions for treatment and an outpatient follow-up visit. Each admission for treatment will be 3 days long and will be separated by 5-9 days. This study is being carried out on behalf of Vectura Limited by Quintiles.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1838

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Favourable Opinion