Clenil® Modulite® Pilot PK study in asthmatic adult patients

• Research type

  Research Study

• Full title

  Pilot, open-label, randomised, repeated dose, 4-way cross-over, clinical pharmacology study of beclomethasone dipropionate (Clenil® Modulite®) 250 µg HFA pMDI using the AeroChamber Plus™ spacer device versus the Volumatic™ spacer device without or with charcoal block in asthmatic adults patients

• IRAS ID

  71162

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2010-022615-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Inhaled corticosteroids (ICS) are widely used to control asthma symptoms, by reducing the inflammation of the airways. The ICS Clenil© Modulite© (beclomethasone dipropionate; BDP) is licensed in the UK for the management of asthma. The Volumatic?½ spacer device must always be used when Clenil© Modulite© is administered to adults and adolescents >16 years of age, taking >1000 micrograms, or when administered to children and adolescents <15 years of age, at any doses. In response to information that Volumatic?½ would be withdrawn by its manufacturer (GSK), Chiesi undertook studies to introduce the AeroChamber Plus?½, a well known valved holding chamber/spacing device, as an alternative spacer for Clenil© Modulite©, eventually replacing Volumatic?½. This is a phase II, monocenter, open-label, randomised, 4-way crossover, repeated dose study, with 4 active treatment periods. The purpose is to compare the systemic exposure (how well the drug is absorbed in the body) of Clenil© Modulite© after repeated inhalations using the AeroChamber Plus?½ and the Volumatic?½ spacer devices. To do this, repeated blood samples will be taken during study visits. The study schedule includes 7 visits, plus one follow-up contact by telephone, as follows:- A consent visit - A screening visit to verify the eligibility of the subject - A randomisation visit followed by four 14-Day randomised treatment periods. Blood samples for PK analysis will be collected at Day 14 of each treatment period - Follow-up contact by phone 3-5 days after the last visit. The four different randomised treatments are: - Clenil© Modulite© with AeroChamber Plus?½; - Clenil© Modulite© with AeroChamber Plus?½ and charcoal block; - Clenil© Modulite© with Volumatic?½; - Clenil© Modulite© with Volumatic?½ and charcoal block. Treatment sequences will ensure that each type of spacer device is used for two consecutive periods. 16 patients will be randomised in order to obtain 12 completed patients

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/H1008/7

• Date of REC Opinion

  28 Mar 2011

• REC opinion

  Further Information Favourable Opinion