Trial reportBritish journal of clinical pharmacology2005
Influence of acute upper respiratory tract infection on the absorption of inhaled insulin using the AERx insulin Diabetes Management System.
Trial report in British journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 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
3 citing papers in PubMed, 42 citations in OpenAlex.
- Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere inhaled insulin.BMJ open diabetes research & care · 2016Article
- Inhaled insulin: overview of a novel route of insulin administration.Vascular health and risk management · 2010Review
- Selection and education of patients for inhaled insulin.Current diabetes reports · 2007Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo assess the effects due to an uncomplicated acute upper respiratory tract infection (URTI) on the pharmacokinetics and glucose response of insulin when delivered by oral pulmonary absorption.
methodsNormally healthy adult men (n = 11) and women (n = 9) received a single dose of inhaled human insulin, equivalent to approximately 6 IU subcutaneous, using the AERx insulin Diabetes Management System (iDMS), during and following recovery from an URTI. The first dose was administered with ongoing symptoms of < 3 days' duration, the second dose following recovery, and within 3 weeks of the first. Blood sampling for determination of insulin pharmacokinetics (serum AUC(0-6 h), AUC(0-8), C(max),t(max), t(1/2), MRT) and glucose response (plasma AOC(0-6 h)) was performed from 15 min predose to 6 h postdose.
resultsInsulin pharmacokinetics were not different for subjects during and following recovery from URTI [e.g. URTI: no URTI ratio in serum AUC(0-6 h) = 0.92 (95% confidence interval 0.81, 1.05)]; this was reflected by a similar glucose response. Inhaled insulin delivered by AERx iDMS was well tolerated by all subjects; no significant changes were observed in pulmonary function tests. No safety concerns arising from the mode of insulin administration were raised by either dose.
conclusionsThe results suggest that insulin can be administered via AERx iDMS to nondiabetic subjects experiencing a URTI without any statistically significant changes in insulin pharmacokinetics or pharmacodynamics, and that the necessity for dose adjustments will not differ from subjects with an acute URTI who are receiving subcutaneous insulin.
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