COMPARATIVE STUDY OF THE SYSTEMIC BIOACTIVITY OF HFA FLUTICASONE PROPIONATE VIA ANTI-STATIC SPACER DEVICES - Systemic Bioactivity of Fluticsone via antistatic spacer devices Ver1

Phase 1

Conditions: Bronchial Asthma

Registration Number: EUCTR2005-005557-22-GB

Lead Sponsor: niversity of Dundee (Research & Innovation)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.Mild to moderate stable asthmatics on =800µg BDP or equivalent
2.Male or female 18-65
3.Informed Consent
4.Ability to comply with the requirements of the protocol

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Severe asthmatics as defined by an FEV1= 60% or PEF variability > 30% or
with continual daytime or nocturnal symptoms.
2.The use of oral corticosteroids within the last 3 months.
3.Recent respiratory tract infection (2 months).
4.Significant concomitant respiratory disease such as COPD, CF, ABPA,
bronchiectasis and active pulmonary tuberculosis.
5.Any other clinically significant medical condition such as unstable angina,
acute myocardial infarction in the preceding 3 months, recent TIA/
CVA,that may endanger the health or safety of the participant, or
jeopardise the protocol.
6.Any significant abnormal laboratory result as deemed by the investigators
7.Pregnancy, planned pregnancy or lactation
8.Known or suspected contra-indication to any of the IMP’s
9.Concomitant use of medicines (prescribed, over the counter or herbal) that
may interfere with the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether, the systemic bioactivity of inhaled fluticasone propionate HFA formulation is comparable via the pMDI, Aerochamber® Max, Zerostat®, and Nebuchamber® devices.;Secondary Objective: ;Primary end point(s): 1.The primary endpoint will be overnight urinary cortisol to creatinine ratio.

Secondary Outcome Measures