Status:
COMPLETED
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
Lead Sponsor:
Brian J Lipworth
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostat...
Detailed Description
Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". Breath actuated integra...
Eligibility Criteria
Inclusion
- Healthy Volunteers
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Exclusion
- No respiratory disease
- Smokers
- Recent respiratory tract infection (2 months).
- 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.
- Any significant abnormal laboratory result as deemed by the investigators
- Pregnancy, planned pregnancy or lactation
- Known or suspected contra-indication to any of the IMP's
- Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01194700
Start Date
November 1 2009
End Date
December 1 2009
Last Update
April 12 2019
Active Locations (1)
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1
Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School
Dundee, Tayside, United Kingdom, DD1 9SY