Last reviewed · How we verify
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
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.
Details
| Lead sponsor | Brian J Lipworth |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 19 |
| Start date | 2009-11 |
| Completion | 2009-12 |
Conditions
- Asthma
Interventions
- Seretide 250(8puffs) via Evohaler actuator
- Seretide 250 (8 puffs)/placebo via Volumatic spacer
- Seretide 250/placebo 8 puffs via Aerochamber Plus spacer
- Seretide 250/placebo via Synchro-Breathe
Primary outcomes
- 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
Countries
United Kingdom