Comparative Relative Lung Bioavailability of HFA-Seretide via spacer devices in healthy volunteers - Lung Bioavailability of HFA-Seretide via spacers

Phase 1

Conditions: Bronchial Asthma

Registration Number: EUCTR2007-003627-20-GB

Lead Sponsor: niversity of Dundee, Research & Innovation Services

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.Healthy Volunteers
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.No respiratory disease
2.Smokers
3.Recent respiratory tract infection (2 months).
4.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.
5.Any significant abnormal laboratory result as deemed by the investigators
6.Pregnancy, planned pregnancy or lactation
7.Known or suspected contra-indication to any of the IMP’s
8.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: 1.To establish whether, the systemic bioavailability of inhaled Seretide® HFA formulation is comparable via the pMDI, Volumatic®, Aerochamber™ Plus and Synchro-breathe devices;Secondary Objective: ;Primary end point(s): 1.The primary endpoint will be overnight urinary cortisol to creatinine ratio as a surrogate for the lung bioavailability of the fluticasone moiety.<br><br>2.The secondary endpoints will be change in serum potassium from baseline as a surrogate for systemic beta adrenoreceptor response of the salmeterol moiety; and early morning urinary cortisol to creatinine ratio as another surrogate of the lung bioavailability of the fluticasone moiety<br>

Secondary Outcome Measures