Clinical trial NCT02403713: A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Mundipharma Research Limited
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
timeFrame: Pre dose to 36 hours post dose
measure: Serum Potassium
timeFrame: Pre Dose to 6 hours post first dose
Secondary outcomes:
measure: Vital Signs
timeFrame: Pre Dose to 6 hours post dose
measure: Serum Glucose
timeFrame: Pre Dose to 6 hours post dose
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
Study officials:
References: