V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-06-08

AUTHORS

Philippe Devillier, Eric Garrigue, Guillaume D’Auzers, Nicolas Monjotin, Thomas Similowski, Thierry Clerc

ABSTRACT

BackgroundLong acting bronchodilators are the standard of care in the management of chronic obstructive pulmonary disease (COPD). The aim of this study was to investigate the efficacy and safety of V0162, a novel anticholinergic agent with bronchodilator properties, in preclinical models and in patients with COPD.MethodsGuinea pigs were used to evaluate the impact of V0162 on the acetylcholine or histamine-induced bronchoconstriction. V0162 was also investigated in an allergic asthma model on ovalbumin-sensitized guinea pig. For clinical investigations, healthy volunteers were included in a dose-escalation, randomized, placebo-controlled phase I study to determine the maximal tolerated dose, followed by a randomized, placebo-controlled, cross-over phase II study in patients with COPD. V0162 was given via inhalation route. The objectives of the phase I/II study were to assess the safety and efficacy of V0162, in terms of bronchodilation and reduction in hyperinflation.ResultsPreclinical results showed that V0162 was able to prevent bronchoconstriction induced either by acetylcholine or histamine. V0162 reversed the bronchoconstriction and airway inflammation caused by ovalbumin challenge in sensitized guinea pigs. In the healthy volunteers study, 88 subjects were enrolled: 66 received V0162 and 22 received placebo. No particular safety concerns were raised. The maximal tolerated dose was not reached and the dose escalation was stopped at 2400 μg. A total of 20 patients with COPD were then enrolled. All patients received a single-dose of V0162 1600 μg and of placebo in two alternating periods. In COPD patients, V0162 demonstrated a significant increase in FEV1 compared with placebo (148 ± 137 ml vs. 36 ± 151 ml, p = 0.003). This bronchodilatory effect was corroborated by a reduction in hyperinflation. There was a trend toward dyspnea relief (change in visual analog scale at 22 h, −15.1 ± 26.0 mm vs.- 5.3 ± 28.8 mm with placebo, p = 0.054). No serious adverse events (AEs) were reported. Most common AEs were productive and non-productive cough, dyspnea and pruritus.ConclusionsV0162 improved pulmonary function and tended to improve dyspnea in patients with COPD over more than 24 h. The slight plasmatic exposure observed might support the good safety profile.Trial registrationClinicalTrials.gov identifier: NCT01348555 More... »

PAGES

68

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12931-015-0227-1

DOI

http://dx.doi.org/10.1186/s12931-015-0227-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1047701403

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26050967


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67 dyspnea
68 dyspnea relief
69 effect
70 efficacy
71 escalation
72 events
73 exposure
74 function
75 good safety profile
76 guinea pigs
77 healthy volunteers
78 histamine
79 hyperinflation
80 identifiers
81 impact
82 increase
83 inflammation
84 inhalation route
85 investigation
86 lung disease
87 management
88 maximal
89 model
90 non-productive cough
91 novel anticholinergic agent
92 objective
93 obstructive lung disease
94 obstructive pulmonary disease
95 ovalbumin challenge
96 ovalbumin-sensitized guinea pigs
97 particular safety concerns
98 patients
99 period
100 phase I
101 phase I/II study
102 phase II study
103 pigs
104 placebo
105 placebo-controlled phase I
106 preclinical models
107 profile
108 properties
109 pruritus
110 pulmonary disease
111 pulmonary function
112 reduction
113 relief
114 results
115 route
116 safety
117 safety concerns
118 safety profile
119 sensitized guinea pigs
120 serious adverse events
121 significant increase
122 standard of care
123 standards
124 study
125 subjects
126 terms
127 total
128 treatment
129 trends
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