Clinical pharmacology study of CHF1535 NEXT DPI versus CHF1535 pMDI

• Research type

  Research Study

• Full title

  A single-dose, open-label, randomized, 2-way crossover, clinical pharmacology study of four inhalations of CHF 1535 100/6 NEXT DPI® (fixed combination of beclomethasone dipropionate 100µg plus formoterol fumarate 6 µg) versus the same dose of CHF 1535 100/6 pMDI both administered with charcoal block.

• IRAS ID

  76396

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2010-024384-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  Not known

• Research summary

  The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new NEXT DPI© dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pMDIusing Aerochamber Plus?½ spacer. To determine lung exposure, the treatments are administered with charcoal block. This helps prevent the study medication being absorbed by the stomach. The new combination beclomethasone/formoterol, to be tested in this study is a dry powder formulation with a new NEXT DPI© inhaler (CHF 1535 100/6 NEXT DPI©, 100 micrograms of beclomethasone and 6 micrograms of formoterol), which is already approved to be delivered via a pressurised metered dose inhaler (pMDI) in Germany since 2006 and is available in 27 European Countries. It is similar to other combination formulations (e.g. Symbicort?½, Seretide?½) which have been available in most European markets for many years for use in adults, in adolescents and in children. This study will be performed according to an open-label, randomised, 2-way crossover, single-dose design. The study will comprise two single dose treatment visits at clinic, separated by a wash-out period (7 days). At each treatment visit, blood sample collection for pharmacokinetic evaluation will be performed. A pre-screening visit (Visit 0) will be carried out to obtain informed consent. The screening visit (Visit 1) will be carried out within 7 days from Visit 0. A maximum of 14 days is allowed between Visit 0 and Visit 2. At screening, eligibility criteria will be evaluated and patients selected. Eligible patients will enter the study which includes a 7 day run-in period and two one-day single dose treatment visits, separated by a 7 day wash-out period. Follow-up phone contact will be performed after 7 days from Visit 3 or after premature discontinuation.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0160

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion