Safety and efficacy of self-administered inhaled loxapine (ADASUVE) in agitated patients outside the hospital setting : Protocol for a phase IV, single-arm, open-label trial
Gil, Emilio (Ferrer Internacional. S.A.)
Garcia-Alonso, Fernando (Ferrer Internacional. S.A.)
Boldeanu, Anca (Ferrer Internacional. S.A.)
Baleeiro Teixeira, Thaïs (Ferrer Internacional. S.A.)
Tordera, Vicente (Hospital Lluís Alcanyis)
Viciedo, Ramón Palmer (Hospital Provincial de Castelló)
Salgado Serrano, Dr Purificación (Hospital del Mar (Barcelona, Catalunya))
Domingo Ribas, Jordi (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Corripio, Iluminada (Institut d'Investigació Biomèdica Sant Pau)
Montes, José Manuel (Hospital Universitario Ramón y Cajal (Madrid))
Lauffer, Javier Correas (Hospital Univ de Henares)
Murugarrem, Salvador Ruiz (Hospital Príncipe de Asturias)
García, Santiago Ovejero (Hospital Universitario Fundación Jiménez Díaz)
Mora, Fernando (Hospital Universitario Infanta Leonor)
López, Presentación Ataz (Complejo Hospitalario Torrecárdenas (Almeria))
Fontalba Navas, Andrés (Hospital la Inmaculada)
Pinto, Ana Mª González (Hospital Santiago Apóstol)
Martínez, Ricardo (Hospital Virgen Del Mirón)
Castrillo, César García (Complejo Hospitalario de Jaen)
Toledo, Francisco (Hospital Universitario Virgen de la Arrixaca (Múrcia))
Vieta, Eduard (Hospital Clínic i Provincial de Barcelona)
González, Emilio (Hermanas Hospitalarias Sociosanitario Palencia)
Franco Martín, Manuel (Complejo Asistencial Zamora)
Drasovean, Nicolae Virgil (Spitalul de Psihiatrie 'Elisabeta Doamna' Galati)
Dahl, Nils Hâvard (Helse Nord-Trøndelag HV Sykehuset Levanger)
Skagen, Bo (Spesialistesenteret På Straume-Helsesenteret)
Zilles, David (Klinik Für Psychiatrie und Psychotherapie der Universitätsmedizin Göttingen)
Zwanzger, Peter (Allgemeinpsychiatrie und Psychosomatik)
Juckel, Georg (LWL-Universitätsklinikum Bochum der Ruhr-Universität Bochum)
Kahl, Kai G. (Medizinische Hochschule Hannover)
Messer, Thomas (Fachklinik Für Psychiatrie)
Kasper, Siegfried (Medizinische Universität Wien Universitätsklinik Für Psychiatrie und Psychotherapie)
Universitat Autònoma de Barcelona

Data:	2018
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Agitation ; Bipolar disorder ; Inhaled loxapine ; Safety ; Self-administration ; Schizophrenia
Publicat a:	BMJ open, Vol. 8 Núm. 10 (january 2018) , p. e020242, ISSN 2044-6055

DOI: 10.1136/bmjopen-2017-020242
PMID: 30282677

7 p, 715.4 KB

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