A Double Blind, Randomised, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Tolerability of Intranasal Fluticasone Propionate Delivered by the Optinose Device in Adult Patients with Bilateral Nasal Polyposis

开始日期2007-03-14

申办/合作机构

OptiNose UK Ltd.

EUCTR2006-005991-41-CZ / Not yet recruitingN/A

A multicentre, double-blind, placebo-controlled evaluation of intranasal sumatriptan delivered with the OptiNose powder device in the treatment of acute migraine.

开始日期2007-03-12

申办/合作机构

OptiNose UK Ltd.

NL-OMON30750 / Suspended临床2期

A single centre, double blind, randomised, parallel group study to explore the efficacy and tolerability of intranasal fluticasone propionate compared with placebo delivered by the OptiNose device in adult subjects with chronic rhinosinusitis. - OptiNose Intranasal Fluticasone Propionate and Chronic Rhinosinusitis

开始日期2007-03-01

申办/合作机构

OptiNose UK Ltd.

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2010-01-08·Journal of Pharmacy and Pharmacology3区 · 医学

Rapid absorption of sumatriptan powder and effects on glyceryl trinitrate model of headache following intranasal delivery using a novel bi-directional device

3区 · 医学

作者: Hewson, Graeme ; Boeijinga, Peter ; Demazières, Agnès ; Luthringer, Remy ; Danjou, Philippe ; Djupesland, Per G ; Flint, Anthony ; Sheldrake, Colin D

AbstractObjectivesThe aim was to investigate the pharmacokinetics of intranasal sumatriptan (administered using a novel bi-directional powder delivery device) and study its effects on quantitative electroencephalography in patients with migraine. The safety profiles of the two formulations were also compared.MethodsThe pharmacokinetics of intranasal sumatriptan (10 mg and 20 mg) administered using a novel breath-actuated bi-directional powder delivery device were compared with subcutaneous sumatriptan (6 mg), along with an investigation of their effects on the electroencephalogram (EEG) following glyceryl trinitrate (GTN) challenge in 12 patients with migraine using a randomized, three-way cross-over design.Key findingsFollowing intranasal delivery, median tmax was 20 min with both doses compared with 10 min after the subcutaneous dose. Mean ± SD values for Cmax were 96 ± 25, 11 ± 7 and 16 ± 6 ng/ml for subcutaneous, intranasal 10 mg and intranasal 20 mg formulations, respectively. Values for area under the curve were also lower with the intranasal doses. Intranasal and subcutaneous sumatriptan induced similar EEG changes characterized by reduced theta-power and increased beta-power. The majority of study participants were free of pain according to the headache severity score with all treatments from 15 min through to 8 h post-dose. All treatments were well tolerated and there were no reports of bitter aftertaste after intranasal delivery. Sumatriptan was rapidly absorbed after intranasal administration using the new device. Using the GTN challenge, sumatriptan powder delivered intranasally at a dose of 20 mg by the new device had effects similar to those of subcutaneous sumatriptan on EEG and reported headache pain, despite much lower systemic exposure.ConclusionsAdministration of sumatriptan intranasally at doses of 10 mg and 20 mg by the breath actuated bi-directional powder delivery device results in rapid absorption. Delivery to target sites beyond the nasal valve induced a similar EEG profile to subcutaneous sumatriptan 6 mg and prevented migraine attacks in patients following GTN challenge. Intranasal administration of sumatriptan powder with the breath actuated bi-directional powder delivery device was well tolerated.

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