Comparing 2 inhalers containing fluticasone and salmeterol; ver 1

• Research type

  Research Study

• Full title

  An open-label, randomized, four-period crossover, single-dose study to compare the pharmacokinetic profiles following four inhalations of Fluticasone Propionate/Salmeterol HFA MDI 125/25 mcg and SeretideTM EvohalerTM 125/25 mcg, with and without charcoal block, administered in healthy volunteers (11-003)

• IRAS ID

  74927

• Contact name

  Steve Warrington

• Eudract number

  2010-024531-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Seretide?½ Evohaler?½ is a combination ofluicasone propionate and salmeterol used to prevent attacks of asthma. Salmeterol works by relaxing the airways anfluicasone propionate works mainly by preventing swelling and inflammation in the airways. The combination ofluicasone propionate and salmeterol is taken via an inhaler that is widely prescribed by doctors in the UK. In this study we will compare the inhaler that is currently prescribed by doctors (Seretide?½ Evohaler?½) with a new inhaler. We will give healthy volunteers single doses ofluicasone propionate and salmeterol on 4 occasions. Each single dose will contain 500 æfluicasone propionate and 100 æg salmeterol. On 2 occasions, participants will takfluicasone propionate and salmeterol from the new inhaler, and on the other 2 occasions, they will take them from the Seretide?½ Evohaler?½. We aim to find out if the new inhaler and the Seretide?½ Evohaler?½ give similar blood levels ofluicasone propionate and salmeterol. The safety of the 2 products will also be monitored. Participants will take about 9 weeks to finish the study. They will make 1 outpatient visit, and stay on the ward for 8 nights in total. A pharmaceutical company (Teva Branded Pharmaceutical Products R&D Inc.) is funding the study. The study will take place at 1 centre in London. A total of about 88 healthy male and female volunteers (aged 18-45 years) will take part in this study. We will recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0008

• Date of REC Opinion

  17 Mar 2011

• REC opinion

  Further Information Favourable Opinion