Charcoal Block Validation & Pulmonary Deposition Comparison Study

• Research type

  Research Study

• Full title

  A charcoal block validation study followed by a single dose, randomised, open-label, 3-treatment, crossover study to compare pulmonary deposition of fluticasone/formoterol breath-actuated inhaler (BAI) and Flutiform® pMDI in healthy volunteers.

• IRAS ID

  121469

• Contact name

  David J A Bell

• Sponsor organisation

  Mundipharma Research Ltd

• Eudract number

  2012-003728-19

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  2 stage study. Stage 1 - charcoal block method validation will determine an activated charcoal dose /schedule of administration to block gastrointestinal absorption of oral formoterol. This information will be used in Stage 2, the main study, which will determine lung deposition ofluicasone/formoterol. Healthy volunteers aged 18 . Screening: = 21 days prior to Day 1 to include tolerance of oral charcoal aqueous suspension acceptability. Stage 2 screening will include inhalation technique training. Study drug - Stage 1 is oral formoterol (gelatine capsule). Stage 1 check-in Day -1, 2 overnight stays in each period. Stage 2 study drug - inhalefluicasone/formoterol. Stage 2, check-in Day -1, 3 overnight stays in each period. Discharge on the morning of Day 2/Day 3 following PK sampling to 24 hours post-dose (stage 1) or 48 hours post-dose (main study) in each period. 7-day washout period after each dosing. Post-study medical 4-7 days after last dosing. AEs recorded throughout. Stage 1: 12 subjects attend a minimum of 4/maximum of 6 periods. In period 1 they will receive an oral dose of formoterol. In subsequent periods subjects will also receive pre and post-dose activated charcoal in an aqueous suspension. Charcoal block regimen will be defined for Study Period 2, and thereafter ongoing following PK data review from the previous period. Stage 1: initially 4 study periods, may extend to 2 extra periods if a satisfactory regimen is not identified from periods 2 to 4. Stage 2: 36 subjects - 3 study periods, randomised to treatment sequencefluicasone/formoterol breath-actuated inhaler (BAI)fluiform pressurised metered-dose inhaler (pMDI) with spacerfluiform pMDI without spacer. Study drug administered on the morning of Day 1, with activated charcoal aqueous suspension pre-dose and post-dose per a satisfactory regimen determined from Stage 1. Total duration - up to 49 days (4 periods) for validation group /42 days for main study group.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  13/EE/0019

• Date of REC Opinion

  29 Jan 2013

• REC opinion

  Further Information Favourable Opinion