A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403713
• Other study ID #: KFL1503
• Secondary ID: 2013-000045-39
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2015
• Last updated: September 25, 2015
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone/formoterol BAI
Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
• Formoterol
Formoterol
• Fluticasone/formoterol PMDI without spacer
Fluticasone/Formoteral 125/5µg pMDI without spacer
• Fluticasone/formoterol PMDI with spacer
Fluticasone/Formoteral 125/5µg pMDI with spacer
• Fluticasone/formoterol PMDI without spacer low dose
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).		Pre dose to 36 hours post dose	No
Primary	Serum Potassium	Maximum reduction in serum potassium from pre-dose.	Pre Dose to 6 hours post first dose	No
Secondary	Vital Signs	Composite measurement of vital signs (heart rate and blood pressure)	Pre Dose to 6 hours post dose	No
Secondary	Serum Glucose	Maximum increase in Serum Glucose	Pre Dose to 6 hours post dose	No