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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02403713

Enrollment

125

Registered

2015-03-31

Start date

2014-08-31

Completion date

2015-09-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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.

Interventions

DRUGFluticasone/formoterol BAI

Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)

DRUGFormoterol

Formoterol

DRUGFluticasone/formoterol PMDI without spacer

Fluticasone/Formoteral 125/5µg pMDI without spacer

DRUGFluticasone/formoterol PMDI with spacer

Fluticasone/Formoteral 125/5µg pMDI with spacer

DRUGFluticasone/formoterol PMDI without spacer low dose

Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or female subjects aged 18 years or over. * Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG. * Normal lung function (FEV1 \>90% of predicted normal value). * Demonstrate satisfactory technique in the use of the study drug devices. * No use of steroid medication (systemic or topical) within 8 weeks prior to study screening.

Exclusion criteria

* Subjects who use any asthma medication or are knowingly regularly exposed to asthma medication. * Any history of drug or alcohol abuse. * Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion. * History of asthma, COPD, or other bronchial or lung diseases. * User of steroid medication (systemic or topical) within 8 weeks prior to study screening.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).	Pre dose to 36 hours post dose	—
Serum Potassium	Pre Dose to 6 hours post first dose	Maximum reduction in serum potassium from pre-dose.

Secondary

Measure	Time frame	Description
Vital Signs	Pre Dose to 6 hours post dose	Composite measurement of vital signs (heart rate and blood pressure)
Serum Glucose	Pre Dose to 6 hours post dose	Maximum increase in Serum Glucose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026