Systemic Exposures of Fluticasone Propionate and Salmeterol Following Inhalation via Metered Dose Inhaler with the Mini Spacer Compared with the Aerochamber Plus Spacer
| Autor: | Mickael Montembault, Noushin Brealey, Francis Warren, Rashmi Mehta, Anshita Gupta, Alison Moore |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male Pharmaceutical Science Pharmacology Fluticasone propionate 03 medical and health sciences Young Adult 0302 clinical medicine Drug Delivery Systems Administration Inhalation London Medicine Humans Pharmacology (medical) 030212 general & internal medicine AEROCHAMBER PLUS Metered Dose Inhalers Adrenergic beta-2 Receptor Agonists Glucocorticoids Time zero Cross-Over Studies Inhalation business.industry Healthy subjects Equipment Design Middle Aged Crossover study Metered-dose inhaler Fluticasone-Salmeterol Drug Combination Healthy Volunteers Bronchodilator Agents 030228 respiratory system Anesthesia Area Under Curve Female Salmeterol business medicine.drug Inhalation Spacers |
| Zdroj: | Journal of aerosol medicine and pulmonary drug delivery. 29(4) |
| ISSN: | 1941-2703 |
| Popis: | The Mini Spacer has been developed for use with Ventolin(®) metered dose inhalers (MDIs) to improve accessibility to affordable spacers in developing countries. To ensure patient safety is not compromised if the Mini Spacer is used off-label with fluticasone propionate (FP) or salmeterol/FP combination (SFC) MDIs (currently not recommended), this study compared the systemic exposure of FP and salmeterol following delivery of FP and SFC MDIs with the Mini Spacer and the Aerochamber Plus(®) spacer (Aerochamber).This was an open-label, randomized, single dose, crossover study in healthy subjects that evaluated four treatments: i) FP 250 μg MDI with Mini Spacer; ii) FP 250 μg MDI with Aerochamber; iii) SFC 25/250 μg with Mini Spacer; iv) SFC 25/250 μg with Aerochamber. There was a minimum 7 day washout between treatments. Pharmacokinetic samples were collected over 24 hours post-dose. The co-primary endpoints were FP area under the concentration-time curve from time zero to 24 h [FP AUC(0-24)] and salmeterol maximum plasma concentration [Cmax].FP systemic exposure in terms of AUC(0-24) was lower following inhalation with the Mini Spacer compared with the Aerochamber for both FP 250 μg (Mini Spacer/Aerochamber Ratio 0.76 [90% CI: 0.57-1.01]) and SFC 25/250 μg (Ratio 0.74 [90% CI: 0.56-0.99]). Salmeterol systemic exposure was also lower following SFC 25/250 μg with Mini Spacer compared with Aerochamber (Cmax Ratio 0.90 [90% CI 0.48-1.66]). The incidence of adverse events was low and similar with each treatment.In the event of use of the Mini Spacer with FP and SFC MDIs, which is not recommended, FP and salmeterol systemic exposure is unlikely to be higher than if MDIs were to be used with the Aerochamber. However, these data do not indicate that the Mini Spacer and Aerochamber are interchangeable. |
| Databáze: | OpenAIRE |
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