Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
Information source: University of Dundee
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Seretide 250(8puffs) via Evohaler actuator (Drug); Seretide 250 (8 puffs)/placebo via Volumatic spacer (Drug); Seretide 250/placebo 8 puffs via Aerochamber Plus spacer (Drug); Seretide 250/placebo via Synchro-Breathe (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Dundee Official(s) and/or principal investigator(s): Arun Nair, Principal Investigator, Affiliation: University of Dundee Brian J Lipworth, Study Director, Affiliation: University of Dundee
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 electrostatic charge within plastic spacers has a clinically relevant impact on the
inhaled steroid delivery.
Clinical Details
Official title: Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Overnight Urinary Cortisol creatinine ratio
Secondary outcome: Serum Potassium
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 integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic
device with a vortex chamber which is designed to be more patient friendly and free from the
effects of electrostatic charge. The systemic bioavailability from the lung of inhaled
fluticasone and salmeterol is dependent on respirable dose delivery, and hence the
performance of inhaler devices can be quantified by measuring the degree of adrenal
suppression and fall in serum potassium(K) as surrogates for delivered lung dose. This
study attempts to compares the systemic bioavailability from the lung in real life
conditions for Fluticasone/Salmeterol combination (measured in terms of relative adrenal
suppression and fall in serum K) via the breath actuated Synchro-Breathe device, pMDI(
Seretide Evohaler), and Aerochamber Plus & Volumatic spacer used brand new "out of the box"
in healthy volunteers.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy Volunteers
2. Male or female 18-65
3. Informed Consent
4. Ability to comply with the requirements of the protocol
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
Locations and Contacts
Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School, Dundee, Tayside DD1 9SY, United Kingdom
Additional Information
Starting date: November 2009
Last updated: September 17, 2010
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