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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

Page last updated: August 23, 2015

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