Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

Phase 4CompletedNCT01194700

Brian J Lipworth19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

Seretide 250(8puffs) via Evohaler actuatorDRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Seretide 250 (8 puffs)/placebo via Volumatic spacerDRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacerDRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School

Dundee, Tayside, United Kingdom

Outcomes

Primary Outcomes

Overnight Urinary Cortisol creatinine ratio

This outcome measure evaluates the amount of cortisol being suppressed after inhaled steroid administration. This helps to assess the systemic effect of steroid inhalation and therefore the propensity for adrenal suppression which is a noted adverse effect with high dose inhaled steroids

Time frame: within 24 hours after study drug inhalation

Secondary Outcomes

Serum Potassium

The serum potassium is monitored 60 minutes post study drug inhalation to assess the systemic beta-2-adrenoreceptor metabolic response. Long acting beta agonists like Salmeterol exhibit dose related reduction in serum potassium.

Time frame: 60 minutes post treatment

Data from ClinicalTrials.gov

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