A PK/PD inhaler comparison study in healthy volunteers.
Research type
Research Study
Full title
A randomised, open label, 2-group, PK (Group 1, 3-period) and PD (Group 2, 5-period) corssover study to compare the systemic exposure and pharmacodynamic effects of fluticasone/formoterol breath-actuated inhaler (BAI) and Flutiform® pMDI in healthy volunteers.
IRAS ID
157473
Contact name
Heather Withers
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2013-000045-39
Research summary
KFL1503 is a 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.
Volunteers aged over 18 years.
Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. Group 2 will only proceed if Group 1 fails to provide comparable results. Group 1, the PK stage may be extended, based on results of the initial PK stage. The extension would enrol a further 42 volunteers.
Screening will be up to 21 days before Day 1 & will also assess ability to use the study treatments.
Group 1 (PK), 48 volunteers, involving 2 overnight stays in 3 different periods. Volunteers receive a single dose of the study drug on the morning of Day 1, discharged on the evening of Day 2. They will undergo blood sampling for PK and safety assessments up to 36 hours post-dose. 7 day washout period between periods.
Group 2 (PD), 35 volunteers, involving 5 overnight stays for 5 periods. Results from the PK stage will determine which study treatment(s) and dosing regimen to include in the PD stage. Volunteers may receive a single dose of matched placebo medication on Day -1, thereafter, 8 doses of study medication every 12 hours, with discharge on Day 5. For one period there may be another overnight stay on Day -3 and a single dose of study medication on Day -2. Alternatively volunteers may receive a single dose of study medication, with discharge on Day 2. Medications are: fluticasone/formoterol pMDI with/without spacer, fluticasone/formoterol BAI, with spacer, formoterol without spacer, and lower dose fluticasone/formoterol without spacer. Volunteers will undergo blood sampling, urine collections and safety assessments up to the morning of discharge. 7 or 14 day washout period between periods, depending on the study design.
Both groups – Post study medical 7 days after last dosing. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.
Study duration will be up to 42 days for Group 1, and up to 111 days for Group 2. Group 1 extension is also up to 42 days.REC name
HSC REC B
REC reference
14/NI/1001
Date of REC Opinion
20 Jun 2014
REC opinion
Favourable Opinion