Chest
Clinical InvestigationsASTHMAEvaluation of the Effect of a Large Volume Spacer on the Systemic Bioactivity of Fluticasone Propionate Metered-Dose Inhaler
Section snippets
Subjects
Fourteen healthy nonsmoking volunteers were recruited into the study. Their mean age (SEM) was 29.9 years old (2.5) and mean percent predicted FEV1 (SEM) was 106% (2.4). The patients were all nonsmokers with no history of respiratory or other disease. In addition, all had normal findings on physical examination, spirometry, urinalysis, and routine hematology/biochemical blood tests. Pregnant women and those taking the oral contraceptive pill were excluded. Approval for the study was obtained
Results
Significant (p < 0.05) suppression of overnight or early morning corrected urinary cortisol/creatinine ratio and serum cortisol occurred with each treatment containing FP, compared to placebo treatment (Fig 1). Furthermore, significant (p < 0.05) additional suppression occurred when comparing FP by pMDI alone to FP by pMDI with spacer (Table 1). This amounted to a twofold difference for effect on 8:00 am serum cortisol and overnight urinary cortisol/creatinine ratio.
Geometric means for
Discussion
Our study confirms the hypothesis that the addition of a large volume spacer to a FP pMDI leads to significantly greater adrenal suppression, a sensitive marker of systemic bioactivity. For effects on 8:00 am serum cortisol and overnight urinary cortisol, there was a twofold increase in mean suppression when using the spacer. This was mirrored by twice as many subjects in the spacer group suppressing their uncorrected urinary cortisol to < 10 nmol/10 h: 86% compared to 43%. As there is almost
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Drug–device interaction for systemic effects of fluticasone in patients with asthma
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2009, Pulmonary Pharmacology and TherapeuticsCitation Excerpt :In this regard the numerical difference between Synchro-Breathe and Volumatic amounted to a 1.05-fold difference (equating to 5.2% difference) in OUCC and a 0.05 mmol/L difference in K (equating to 1.3% difference). Dempsey et al. [22] in healthy volunteers had previously demonstrated that the use of VM spacer with CFC–FP via pMDI increased the suppression of OUCC by nearly 1.9-fold, as compared to a value of 1.66-fold greater suppression with HFA–FP in the present study. In this regard a greater degree OUCC suppression with CFC vs. HFA–FP has been previously documented [26,27] when using pMDI alone in either healthy volunteers or asthmatics.
Fluticasone propionate in children and infants with asthma
2007, Archives de Pediatrie
This study was funded by a University of Dundee research grant andreceived no funding from the pharmaceutical industry.