A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers
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
2 other identifiers
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Aug 2014
Typical duration for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 28, 2015
September 1, 2015
2 months
February 19, 2015
September 25, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
Pre dose to 36 hours post dose
Serum Potassium
Maximum reduction in serum potassium from pre-dose.
Pre Dose to 6 hours post first dose
Secondary Outcomes (2)
Vital Signs
Pre Dose to 6 hours post dose
Serum Glucose
Pre Dose to 6 hours post dose
Study Arms (5)
Test Treatment
EXPERIMENTALFluticasone/formoterol 125/5 µg BAI
Active Comparator 1
ACTIVE COMPARATORFluticasone/formoterol 125/5 µg pMDI with spacer
Active Comparator 2
ACTIVE COMPARATORFluticasone/formoterol 125/5 µg pMDI without spacer
Active Comparator 3
ACTIVE COMPARATORFluticasone/formoterol pMDI (125/5 μg) without spacer, low dose
Active Comparator 4
ACTIVE COMPARATORFormoterol (12 µg) without spacer
Interventions
Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
Fluticasone/Formoteral 125/5µg pMDI without spacer
Fluticasone/Formoteral 125/5µg pMDI with spacer
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Belfast, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2015
First Posted
March 31, 2015
Study Start
August 1, 2014
Primary Completion
October 1, 2014
Study Completion
September 1, 2015
Last Updated
September 28, 2015
Record last verified: 2015-09