A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

September 25, 2015 updated by: Mundipharma Research Limited

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Treatment
Fluticasone/formoterol 125/5 µg BAI
Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
Active Comparator: Active Comparator 1
Fluticasone/formoterol 125/5 µg pMDI with spacer
Fluticasone/Formoteral 125/5µg pMDI with spacer
Active Comparator: Active Comparator 2
Fluticasone/formoterol 125/5 µg pMDI without spacer
Fluticasone/Formoteral 125/5µg pMDI without spacer
Active Comparator: Active Comparator 3
Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
Active Comparator: Active Comparator 4
Formoterol (12 µg) without spacer
Formoterol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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