- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692978
Pharmacokinetics of Inhaled Monodisperse Fluticasone Propionate
The Pharmacokinetics of Inhaled Fluticasone Propionate Delivered as Monodisperse Aerosols
Asthma is most effectively treated by delivering inhaled drugs from an inhaler (puffer) directly into the lungs. Inhaled steroids are used in asthmatic patients to dampen down lung inflammation, which unchecked, can often lead to patient symptoms. Inhalers deliver a mist containing particles of lots of different sizes (like hairsprays). Medical puffers used by patients produce a 'coarse' mist of drug particles, which have the potential for side effects, as different sized particles will reach different parts of the airways and include; the mouth, the throat, the windpipe, and the bloodstream (all places we do not want the inhaled drug to go - and can give rise to important side effects)and, the lungs (where we do want the drug to 'deposit').
Our aim in this study is to test an inhaled steroid by giving it to subjects as a 'fine' mist containing drug particles of nearly all one size using a research nebuliser (a Spinning Top Aerosol Generator). We shall use small, intermediate and large drug particle mists. We aim to find out how much of the drug goes to the blood stream for each particle mist and compare it with the standard puffers used in routine clinical practice.
We hope this study will provide information to the rationale that by improving the efficiency of drug delivery (by changing drug particle size) one may improve inhaled drug delivery and ultimately, clinical patient benefit.
Healthy volunteers and asthmatic patients will be recruited at the Royal Brompton Hospital London. The study is funded by GlaxoSmithKline, Research & Development, U.K.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Asthma Lab, Royal Brompton Hospital
-
London, United Kingdom
- Department of Nuclear Medicine, Royal Brompton Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy Volunteers
Participants will be included if they meet all of the following inclusion criteria
- Healthy non smoking participants
- Male or female aged above 18 years
- No history of respiratory disease
- Normal baseline spirometry as predicted for age, sex and height (we have excluded those with abnormal spirometry as this may indicate an underlying lung condition that needs attention, and such participants will be told their result and with their consent, the information will be forwarded to their General Practitioner, as part of the safety and well being of the research participant.
- No history of allergic disease i.e., a negative skin prick test
- Participants who are free from significant cardiac, gastrointestinal, hepatic, renal, hematological, neurological and psychiatric disease.
- Not taking any regular medication that is contraindicated in those about to receive fluticasone propionate (as indicated in the British National Formularly); other than the oral contraceptive pill.
Asthmatics
- Male or females aged greater than 18 years with a documented history of reversible airways disease responding to beta2-adrenergic therapy.
- Asthmatic patients who are free from significant cardiac, gastrointestinal, hepatic, renal, hematological, neurological and psychiatric disease.
- Patients who are stabilized on 500 micrograms or less of inhaled beclomethasone dipropionate or alternative inhaled corticosteroid (budesonide or ciclesonide).
- Patients who are able and willing to give written informed consent to take part in the study
- Not taking any regular medication that is contraindicated in those about to receive fluitcasone propionate (as indicated in the British National Formularly); other than the oral contraceptive pill.
Exclusion Criteria:
Healthy Volunteers and Asthmatics
- Those requiring maintenance oral or parenteral corticosteroid therapy for their airways disease or patients who have ceased maintenance oral or parenteral corticosteroid therapy within the four weeks prior to visit 1
- Those requiring greater than 500 micrograms of inhaled beclomethasone dipropionate or alternative inhaled corticosteroid (budesonide or ciclesonide).
- Subjects that have received inhaled or intravenous fluticasone propionate in the last 2 months.
- Those whose reversible airways obstruction has been unstable in the last four weeks (indicated by any change in their maintenance therapy).
- Those participants who have had a lower respiratory tract infection in the previous four weeks
- Those who have donated 450ml blood or more within the previous 1 month.
- Those who have a history of drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study.
- Any evidence of a positive pregnancy urine test for female volunteers or females who are pregnant or lactating or are likely to become pregnant during the trial. Women of child-bearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
- Participants with a known or suspected allergy to corticosteroids or any component of the formulations and/or Suspected hypersensitivity to inhaled corticosteroid (this will be asked directly at the screening visit).
- Any patient with a contraindication to taking an inhaled steroid and specifically FP, listed in the British National Formularly will not be entered into this study
- Those who have experienced an acute asthma exacerbation requiring emergency room treatment and/or hospitalization within one month of visit 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Asthma
Asthma patients
|
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 6.0 microns, inhaled
Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler
|
ACTIVE_COMPARATOR: Healthy volunters
Healthy participants
|
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled
Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 6.0 microns, inhaled
Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC Fluticasone Propionate (FP)
Time Frame: 12 hours
|
The main outcome measure is the concentration of Fluticasone Propionate in blood following inhalation of the dose.
This will be found by calculating the area under the curve of concentration versus time 0 and 12 hours.
|
12 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: O S Usmani, MD, PhD, Imperial College London
Publications and helpful links
General Publications
- Biddiscombe MF, Barnes PJ, Usmani OS. Generating monodisperse pharmacological aerosols using the spinning-top aerosol generator. J Aerosol Med. 2006 Fall;19(3):245-53. doi: 10.1089/jam.2006.19.245.
- Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
- Usmani OS, Biddiscombe MF, Nightingale JA, Underwood SR, Barnes PJ. Effects of bronchodilator particle size in asthmatic patients using monodisperse aerosols. J Appl Physiol (1985). 2003 Nov;95(5):2106-12. doi: 10.1152/japplphysiol.00525.2003. Epub 2003 Aug 1.
- Biddiscombe MF, Usmani OS, Barnes PJ. A system for the production and delivery of monodisperse salbutamol aerosols to the lungs. Int J Pharm. 2003 Mar 26;254(2):243-53. doi: 10.1016/s0378-5173(03)00032-2.
Study record dates
Study Major Dates
Study Start (ACTUAL)
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/H0712/63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Fluticasone Propionate_1.5
-
GlaxoSmithKlineCompleted
-
West Penn Allegheny Health SystemCompleted
-
University of FloridaFood and Drug Administration (FDA)Completed
-
University of DundeeCompletedAsthma | Allergic RhinitisUnited Kingdom
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Germany, Romania, Russian Federation, Ukraine, Chile, Sweden, Mexico, Netherlands, Poland
-
GlaxoSmithKlineCompletedAsthmaGermany, Romania, Bulgaria, Chile, Russian Federation, South Africa, Estonia, Italy, Mexico, Greece, Hungary, Croatia, Brazil
-
University of MilanTerminatedBronchiectasis | Pulmonary Disease | Chronic BronchitisItaly
-
GlaxoSmithKlineCompletedAsthmaUnited States, Germany, Romania, Poland, Belgium