A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

Mundipharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Formoterol; Drug: Fluticasone/formoterol PMDI with spacer; Drug: Fluticasone/formoterol PMDI without spacer; Drug: Fluticasone/formoterol PMDI without spacer low dose; Drug: Fluticasone/formoterol BAI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403713

KFL1503

2013-000045-39 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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125 participants in 5 patient groups

Test Treatment

Experimental group

Description:

Fluticasone/formoterol 125/5 µg BAI

Treatment:

Drug: Fluticasone/formoterol BAI

Active Comparator 1

Active Comparator group

Description:

Fluticasone/formoterol 125/5 µg pMDI with spacer

Treatment:

Drug: Fluticasone/formoterol PMDI with spacer

Active Comparator 2

Active Comparator group

Description:

Fluticasone/formoterol 125/5 µg pMDI without spacer

Treatment:

Drug: Fluticasone/formoterol PMDI without spacer

Active Comparator 3

Active Comparator group

Description:

Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose

Treatment:

Drug: Fluticasone/formoterol PMDI without spacer low dose

Active Comparator 4

Active Comparator group

Description:

Formoterol (12 µg) without spacer

Treatment:

Drug: Formoterol