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A Randomized Clinical Study of Levodropropizine Effect on Respiratory Center Output in Healthy Volunteers and Patients With Chronic Cough FREE TO VIEW

Giovanni Fontana, MD; Luigi Lanata, MD; Francesco De Blasio, MD; Federico Saibene, MD; Alessandra Monguzzi, MD; Alessandro Zanasi, MD
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Dompè, Milano, Italy

Chest. 2014;146(4_MeetingAbstracts):530A. doi:10.1378/chest.1991395
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SESSION TITLE: Quality & Clinical Improvement Posters I

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: Levodropropizine is an effective and well tolerated orally-administered non-opioid antitussive drug, exerting its action mainly through inhibition of the cough reflex at the peripheral airway sensory nerves (C-fibres), with modulation of sensory neuropeptide release within the respiratory tract. Peripheral action of levodropropizine is well ascertained but the effects of its therapeutic doses at the central level have been poorly studied. The aim of this study is to evaluate the effect of levodropropizine (60 mg) on respiratory center motor output, as compared to placebo and dihydrocodeine (15 mg), a respiratory depressant centrally acting drug

METHODS: This is a single-center prospective randomized cross-over study carried on 24 patients of both sexes, aged 20-70 years (12 healthy volunteers and 12 patients with chronic cough, lasting for longer than 8 weeks and without any significant improvement). Ventilatory responses to standard CO2 rebreathing challenge test are assessed in study subjects by spirometry and electromyography of respiratory muscles, under baseline conditions and following administration of a single dose of each study medication, according to a cross-over design in a randomized sequence with a 1-week interval between treatments. Sample size was statistically calculated for significance level of 0.05 and study power of 80%

RESULTS: The study is just starting, but due to its short duration of few months, results on hypercapnic ventilatory response will be available shortly for primary and secondary outcome variables. Results on changes in mean inspiratory drive, mean inspiratory flow, inspiratory pressure at airway occlusion, minute ventilation and inspiratory muscle activity during CO2 challenge after the administration of levodropropizine, dihydrocodeine and placebo will be presented, with multiple comparisons between study treatments, in both study population

CONCLUSIONS: Results of this study will provide new evidence on the effects of therapeutic doses of levodropropizine on respiratory center output in order to ascertain whether this peripheral antitussive agent is devoid of any significant action at the central level

CLINICAL IMPLICATIONS: Our findings will help clarify definitively the peripheral action of this widely used antitussive drug, supporting its favorable benefit/risk profile in management of cough in adults and especially in childrens.

DISCLOSURE: Giovanni Fontana: Other: Unrestricted grat Luigi Lanata: Employee: medical affairs director Federico Saibene: Employee: medical manager Alessandra Monguzzi: Employee: medical affairs officer The following authors have nothing to disclose: Francesco De Blasio, Alessandro Zanasi

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