A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

Mundipharma Research Limited125 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Asthma

Interventions

Fluticasone/formoterol BAIDRUG

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

FormoterolDRUG

Formoterol

Fluticasone/formoterol PMDI without spacerDRUG

Fluticasone/Formoteral 125/5µg pMDI without spacer

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Belfast, United Kingdom

Outcomes

Primary Outcomes

Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).

Time frame: Pre dose to 36 hours post dose

Serum Potassium

Maximum reduction in serum potassium from pre-dose.

Time frame: Pre Dose to 6 hours post first dose

Secondary Outcomes

Vital Signs

Composite measurement of vital signs (heart rate and blood pressure)

Time frame: Pre Dose to 6 hours post dose

Serum Glucose

Maximum increase in Serum Glucose

Time frame: Pre Dose to 6 hours post dose

Data from ClinicalTrials.gov

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