Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting

There is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of...

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Autores: Gil, Emilio, Garcia-Alonso, Fernando, Boldeanu, Anca, Baleeiro Teixeira, Thaïs, Tordera, Vicente, Viciedo, Ramón Palmer, Salgado Serrano, Dr Purificación|||0000-0003-4551-2264, Domingo Ribas, Jordi, Corripio, Iluminada|||0000-0003-2562-711X, Montes, José Manuel|||0000-0002-2030-5253, Lauffer, Javier Correas, Murugarrem, Salvador Ruiz, García, Santiago Ovejero, Mora, Fernando|||0000-0003-4698-1679, López, Presentación Ataz, Fontalba Navas, Andrés, Pinto, Ana Mª González, Martínez, Ricardo, Castrillo, César García, Toledo, Francisco, Vieta, Eduard|||0000-0002-0548-0053, González, Emilio, Franco Martín, Manuel|||0000-0002-3639-2523, Drasovean, Nicolae Virgil, Dahl, Nils Hâvard, Skagen, Bo, Zilles, David, Zwanzger, Peter, Juckel, Georg, Kahl, Kai G., Messer, Thomas, Kasper, Siegfried
Tipo de recurso: artículo
Fecha de publicación:2018
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:286890
Acceso en línea:https://ddd.uab.cat/record/286890
https://dx.doi.org/urn:doi:10.1136/bmjopen-2017-020242
Access Level:acceso abierto
Palabra clave:Agitation
Bipolar disorder
Inhaled loxapine
Safety
Self-administration
Schizophrenia
Descripción
Sumario:There is a need for fast-acting, non-injection antiagitation treatments that are well tolerated and can be used outside of healthcare facilities. In phase II/III trials, an inhaled formulation of loxapine (ADASUVE®), a well-established, first-generation antipsychotic agent, provided rapid control of mild to moderate agitation in the hospital setting. The present study was designed to investigate the safety and efficacy of inhaled loxapine when self-administered outside the hospital setting. This phase IV, multicentre, single-arm, open-label clinical trial is being conducted in five countries in Europe: Spain, Germany, Norway, Romania and Austria. The aim is to include approximately 500 patients with schizophrenia or bipolar disorder who previously received and responded well to inhaled loxapine in the hospital setting. Eligible patients will be followed up for 6 months from baseline. They will be given a 10 mg dose of inhaled loxapine to self-administer outside the hospital setting to treat an agitation episode, should one occur. Patients will also be given a short-acting beta-agonist bronchodilator for treatment of possible severe respiratory side effects. The primary endpoint is incidence of serious adverse events (AEs) and respiratory AEs of special interest related to use of inhaled loxapine outside the hospital setting. Secondary endpoints include incidence of other AEs, Clinical Global Impression-Improvement scores up to 2 hours after self-administration of inhaled loxapine, time to improvement of agitation, patient satisfaction with treatment, treatment outcomes according to agitation severity and concordance between the patient (or a family member/caregiver) and the physician in scoring of agitation severity and the decision to self-administer inhaled loxapine. The protocol received ethics committee approval in the participating countries between January and August 2016. The results of this study will be disseminated through one or more scientific papers. Trial registration number EudraCT2015-003331-36; NCT02525991; Pre-results.

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