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| Sponsor: | Imperial College London |
|---|---|
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00692978 |
Purpose
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 effiency 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Asthma |
Drug: Fluticasone Propionate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | The Pharmacokinetics of Inhaled Fluticasone Propionate Delivered as Monodisperse Aerosols |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Monodisperse aerosols inhaled of Fluticasone Propionate 1.5microns size at 50micrograms dose with double-dummy placebo MDI inhaler
|
Drug: Fluticasone Propionate
Dose 50 micrograms (total dose), Monodisperse aerosol with diofferemt particle size of drug (1.5, 3.0, 6.0 microns), inhaled
|
|
2: Experimental
Monodisperse aerosols inhaled of Fluticasone Propionate 3.0microns size at 50micrograms dose with double-dummy placebo MDI inhaler
|
Drug: Fluticasone Propionate
Dose 50 micrograms (total dose), Monodisperse aerosol with diofferemt particle size of drug (1.5, 3.0, 6.0 microns), inhaled
|
|
3: Experimental
Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler
|
Drug: Fluticasone Propionate
Dose 50 micrograms (total dose), Monodisperse aerosol with diofferemt particle size of drug (1.5, 3.0, 6.0 microns), inhaled
|
|
4: Experimental
etered dose inhaler of Fluticasone Propionate 250 micrograms dose, inhaled, with double-dummy placebo monodisperse aerosol
|
Drug: Fluticasone Propionate
Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)
|
The clinical trial is to investigate the pharmacokinetic effects (that is how much drug is in the blood) of Fluticasone Propionate (Flixotide), a commonly used steroid drug that is inhaled in patients with asthma. We will use standard clinical Flixotide Nebules that are used with clinical nebulisers (machines used in hospital and at home − to deliver drug to patients with asthma). Current clinical nebulisers deliver a 'coarse' mist of drug, which has the potential for side effects and this is an important consideration with steroids. These Flixotide nebules will be used to deliver the drug (fluticasone propionate) as monodiperse aerosol clouds (that is the drug will be delivered as a 'fine' mist cloud to patients). In order to deliver the drug as a monodisperse aerosol, the Flixotide Nebules will be used with a spinning top aerosol (a large research nebuliser machine)which is able to selectively generate aerosol clouds that have a fine mist. A fine mist cloud leads to less deposition in the throat of the patients and a greater control of the inhaled drug reaching the lungs, and fine mist drug clouds have the potential to reduce side efects. We will also compare this to the use of a standard routine clinical dose of a Flixotide metered−dose inhaler ( a 'press and breathe' inhaler) with a spacer (plastic bubble on the end of an inhaler) delivered to patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy Volunteers
Participants will be included if they meet all of the following inclusion criteria
Asthmatics
Exclusion Criteria:
Healthy Volunteers and Asthmatics
Contacts and Locations| United Kingdom | |
| Asthma Lab, Royal Brompton Hospital | |
| London, United Kingdom | |
| Department of Nuclear Medicine, Royal Brompton Hospital | |
| London, United Kingdom | |
| Principal Investigator: | O S Usmani, MD, PhD | Imperial College London |
More Information
| Responsible Party: | Imperial College London ( Dr O S Usmani ) |
| Study ID Numbers: | 08/H0712/63 |
| Study First Received: | June 4, 2008 |
| Last Updated: | January 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00692978 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Monodisperse aerosols Healthy Volunteers Asthmatics Pharmacokinetics Randomized |
|
Anti-Inflammatory Agents Respiratory System Agents Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Anti-Asthmatic Agents |
Fluticasone Anti-Allergic Agents Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pharmacologic Actions |