Asthma
Conditions
Keywords
lung bioavailability, asthma, seretide, Spacer
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 electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.
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.
Interventions
DRUGSeretide 250(8puffs) via Evohaler actuator
8 puffs of Seretide250/Placebo via Evohaler actuator
DRUGSeretide 250 (8 puffs)/placebo via Volumatic spacer
8 puffs of Seretide 250/placebo via volumatic spacer
DRUGSeretide 250/placebo 8 puffs via Aerochamber Plus spacer
Seretide 250/placebo 8 puffs via Aerochamber Plus
DRUGSeretide 250/placebo via Synchro-Breathe
Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device
Sponsors
Brian J Lipworth
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Urinary Cortisol creatinine ratio | within 24 hours after study drug inhalation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Potassium | 60 minutes post treatment | 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. |
Countries
United Kingdom
Outcome results
None listed