A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers
NCT ID: NCT02403713
Last Updated: 2015-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
125 participants
INTERVENTIONAL
2014-08-31
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Test Treatment
Fluticasone/formoterol 125/5 µg BAI
Fluticasone/formoterol BAI
Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
Active Comparator 1
Fluticasone/formoterol 125/5 µg pMDI with spacer
Fluticasone/formoterol PMDI with spacer
Fluticasone/Formoteral 125/5µg pMDI with spacer
Active Comparator 2
Fluticasone/formoterol 125/5 µg pMDI without spacer
Fluticasone/formoterol PMDI without spacer
Fluticasone/Formoteral 125/5µg pMDI without spacer
Active Comparator 3
Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose
Fluticasone/formoterol PMDI without spacer low dose
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
Active Comparator 4
Formoterol (12 µg) without spacer
Formoterol
Formoterol
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Mundipharma Research Limited
INDUSTRY
Responsible Party
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Locations
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Belfast, , United Kingdom
Countries
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Other Identifiers
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2013-000045-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KFL1503
Identifier Type: -
Identifier Source: org_study_id
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