The Pharmacokinetics of Inhaled Fluticasone Propionate delivered as Monodisperse Aerosols - Pharmacokinetics of inhaled monodisperse Fluticasone Propionate

• Conditions: Healthy volunteers and mild to moderate asthma; MedDRA version: 9.1Level: LLTClassification code 10052996Term: Inhalation therapy; MedDRA version: 9.1Level: LLTClassification code 10053349Term: Pharmacokinetic study; MedDRA version: 9.1Level: PTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2008-002139-34-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy Volunteers
Participants will be included if they meet all of the following inclusion criteria;
1) Healthy non smoking participants
2) Male or female aged above 18 years
3) No history of respiratory disease
4) 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.
5) No history of allergic disease i.e., a negative skin prick test
6) Participants who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological,
neurological and psychiatric disease.
7) 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.

Asthmatics
1) Male or females aged greater than 18 years with a documented history of reversible airways disease
responding to beta2-adrenergic therapy.
2) Asthmatic patients who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological,
neurological and psychiatric disease.
3) Patients who are stabilized on 500 micrograms or less of inhaled beclomethasone dipropionate or
alternative inhaled corticosteroid (budesonide or ciclesonide).
4) Patients who are able and willing to give written informed consent to take part in the study
5) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Healthy Volunteers and Asthmatics
1) 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
2) Those requiring greater than 500 micrograms of inhaled beclomethasone dipropionate or alternative
inhaled corticosteroid (budesonide or ciclesonide).
3) Subjects that have received inhaled or intravenous fluticasone propionate in the last 2 months.
4) Those whose reversible airways obstruction has been unstable in the last four weeks (indicated by any
change in their maintenance therapy).
5) Those participants who have had a lower respiratory tract infection in the previous four weeks
6) Those who have donated 450ml blood or more within the previous 1 month.
7) Those who have a history of drug allergy which, in the opinion of the Unit Physician, contraindicates
his/her participation in the study.
8) 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.
9) 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).
10) 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
11) Those who have experienced an acute asthma exacerbation requiring emergency room treatment and/or
hospitalisation within one month of visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified