Next™ DPI LABA in asthma, version PR-0038

• Research type

  Research Study

• Full title

  A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2008-004842-10

• Research summary

  In asthma treatment, inhaled corticosteroids (ICS) and long acting beta-2-agonists (LABA) are medications taken daily on a long-term basis to keep asthma under control. Chiesi has a combination formulation of beclomethasone (BDP) and formoterol (FF), called Fostair in the UK, which is licensed for use in a pressurized metered dose inhaler (pMDI) form. Chiesi is now developing this combination with a new dry powder inhaler (DPI), called NEXT DPI. This new device is capable of delivering the dose through a breath-actuated mechanism, triggering dose delivery with low inspiratory effort, and has been designed for easy use by patients. The aim of the proposed clinical study is to demonstrate that the combination drug delivered via the DPI, is at least as effective as the marketed combination drug given via pMDI, in terms of improvement of pulmonary function.The study is in adults with partly controlled asthma (definition according to the GINA guidelines, 2006), taking a specified daily dose of ICS. They must be non-smokers or ex-smokers (less than 5 pack-years history) and meet required lung function tests at screening. For each patient, the study will last between 6-9 weeks. Patients will need to visit the clinic 7 times (pre-screening, screening and 5 treatment visits). At treatment visits, patients will use 2 pMDI and 2 DPI inhalers, receiving a combination of BDP or placebo. Over the course of 5 treatment visits, each patient will have received each of the 5 combinations of treatment; one of these arms will be purely placebo. A follow-up contact by phone will be performed after the last visit. The study is funded by Chiesi Farmaceutici S.p.A., based in Italy and will include 1 UK site. It is hoped 40 patients will be recruited in the UK and a total of 65 patients across UK, Italy and France.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/204

• Date of REC Opinion

  14 Jan 2009

• REC opinion

  Further Information Favourable Opinion