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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003627-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evohaler | Experimental |
| |
| Volumatic spacer | Experimental |
| |
| Aerochamber Plus | Experimental |
| |
| Synchro-Breathe | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seretide 250(8puffs) via Evohaler actuator | Drug | 8 puffs of Seretide250/Placebo via Evohaler actuator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 24 hours after study drug inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Nair | University of Dundee | Principal Investigator |
| Brian J Lipworth | University of Dundee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School | Dundee | Tayside | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21240480 | Result | Nair A, McKinlay L, Williamson P, Short P, Burns P, Lipworth BJ. Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. Eur J Clin Pharmacol. 2011 Apr;67(4):355-363. doi: 10.1007/s00228-010-0989-9. Epub 2011 Jan 15. |
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|
| Seretide 250 (8 puffs)/placebo via Volumatic spacer | Drug | 8 puffs of Seretide 250/placebo via volumatic spacer |
|
|
| Seretide 250/placebo 8 puffs via Aerochamber Plus spacer | Drug | Seretide 250/placebo 8 puffs via Aerochamber Plus |
|
|
| Seretide 250/placebo via Synchro-Breathe | Drug | Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device |
|
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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