- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403713
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Belfast, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
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Active Comparator: Active Comparator 1
Fluticasone/formoterol 125/5 µg pMDI with spacer
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Fluticasone/Formoteral 125/5µg pMDI with spacer
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Active Comparator: Active Comparator 2
Fluticasone/formoterol 125/5 µg pMDI without spacer
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Fluticasone/Formoteral 125/5µg pMDI without spacer
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Active Comparator: Active Comparator 3
Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose
|
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
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Active Comparator: Active Comparator 4
Formoterol (12 µg) without spacer
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Formoterol
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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
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Pre dose to 36 hours post dose
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Serum Potassium
Time Frame: Pre Dose to 6 hours post first dose
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Maximum reduction in serum potassium from pre-dose.
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Pre Dose to 6 hours post first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital Signs
Time Frame: Pre Dose to 6 hours post dose
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Composite measurement of vital signs (heart rate and blood pressure)
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Pre Dose to 6 hours post dose
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Serum Glucose
Time Frame: Pre Dose to 6 hours post dose
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Maximum increase in Serum Glucose
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Pre Dose to 6 hours post dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Formoterol Fumarate
Other Study ID Numbers
- KFL1503
- 2013-000045-39 (EudraCT Number)
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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