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COMPARATIVE LUNG BIOAVAILABILITY OF HFA-SERETIDE VIA SPACER DEVICES IN HEALTHY VOLUNTEERS - Systemic bioavailability of Seretide via spacer devices

Phase 1
Conditions
Bronchial Asthma
Registration Number
EUCTR2006-001104-36-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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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