Trial reportClinical pharmacokinetics2000
Pharmacokinetics of fluticasone propionate inhaled via the Diskhaler and Diskus powder devices in healthy volunteers.
Trial report in Clinical pharmacokinetics, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.Clinical pharmacology and therapeutics · 2017Trial
- Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 µg Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler.Clinical drug investigation · 2015Trial
- Pharmacokinetics of fluticasone propionate inhaled via the Diskhaler and Diskus powder devices in patients with mild-to-moderate asthma.Clinical pharmacokinetics · 2000Trial
- Comparison of the systemic availability of fluticasone propionate in healthy volunteers and patients with asthma.Clinical pharmacokinetics · 2000Trial
- A new method for investigating bioequivalence of inhaled formulations: A pilot study on salbutamol.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2023Article
- Inhaled corticosteroids: potency, dose equivalence and therapeutic index.British journal of clinical pharmacology · 2015Review
- Pharmacokinetic/pharmacodynamic evaluation of urinary cortisol suppression after inhalation of fluticasone propionate and mometasone furoate.British journal of clinical pharmacology · 2007Article
- In vitro metabolism of beclomethasone dipropionate, budesonide, ciclesonide, and fluticasone propionate in human lung precision-cut tissue slices.Respiratory research · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of these studies was to determine the absolute bioavailability in healthy volunteers of inhaled fluticasone propionate (FP) administered as a single dose via the Diskhaler and Diskus powder devices, and the pharmacokinetics of inhaled FP after repeated administration via the Diskhaler device.
methodsIn 2 of the studies, single inhaled doses of FP were administered via the Diskhaler and the Diskus powder devices, and, in the third study, repeated doses of FP were administered via the Diskhaler. In the single dose studies, 12 healthy volunteers were randomised to receive FP 1000 microg by inhalation and FP 250 microg intravenously, using a double-blind crossover design. In the repeated dose study, 24 healthy volunteers received FP 1000 microg twice daily for 7.5 days.
resultsSystemic exposure to FP after administration of a single 1000 microg inhaled dose of FP via the 2 powder devices was similar; the area under the plasma FP concentration-time curve (AUC) to infinite time (AUCinfinity) was 2.08 microg/L x h [95% confidence intervals (CI): 1.63-2.64] for Diskhaler and 2.49 microg/L x h (95% CI: 2.09-2.96) for Diskus. Maximum plasma FP concentration (Cmax) was 0.34 microg/L for both devices. Mean bioavailability values via the Diskhaler and Diskus were 11.9% (95% CI: 9.0-15.7%) and 16.6% (95% CI: 13.6-20.3%), respectively. No clinically significant reductions in urinary cortisol excretion were recorded in these 2 studies. After repeated administration with the Diskhaler, steady state was achieved by dose 3 (i.e. day 2) onwards. After dose 15, the AUC up to 12 hours (AUC12h) was 2.25 microg/L x h and Cmax was 0.38 microg/L. The mean steady-state to single dose accumulation ratio after twice-daily administration was 1.49 (95% CI: 1.36-1.62).
conclusionThe pharmacokinetics of FP administered by the 2 powder devices are similar in healthy volunteers, although systemic bioavailability was greater with the Diskus.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.