NCT02403713

A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

A Randomised, Open-label, 2-group PK (3-period) and PD (5-period) Crossover Study to Compare Systemic Exposure and Pharmacodynamic Effects of Fluticasone/Formoterol BAI and pMDI in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.

Detailed description

Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. PK interim analysis to determine requirement for PK extension. Group 1 (PK) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. Results from PK stage will determine if Group 2 (PD) is required. Group 2 (PD) will assess LABA only effects (as confirmed in interim analysis). Group 2 (PD) to include 2 overnight stays for 5 study periods. Volunteers will receive a single dose of study medication, with discharge on Day 2. Study treatments are fluticasone/formoterol BAI, fluticasone/formoterol pMDI with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer. Volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone/formoterol BAI	Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
DRUG	Formoterol	Formoterol
DRUG	Fluticasone/formoterol PMDI without spacer	Fluticasone/Formoteral 125/5µg pMDI without spacer
DRUG	Fluticasone/formoterol PMDI with spacer	Fluticasone/Formoteral 125/5µg pMDI with spacer
DRUG	Fluticasone/formoterol PMDI without spacer low dose	Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2015-09-01
• First posted: 2015-03-31
• Last updated: 2015-09-28

Locations

1 site across 1 country: United Kingdom