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
Por:
Gil, E, Garcia-Alonso, F, Boldeanu, A, Teixeira, T, Tordera, V, Palmer Viciedo, R, Salgado, P, Domingo Ribas, J, Corripio Collado, I, Manuel Montes, J, Correas Lauffer, J, Ruiz Murugarrem, S, Ovejero Garcia, S, Mora, F, Lopez, A, Fontalba Navas, A, Gonzalez Pinto, A, Martinez, R, Garcia Castrillo, C, Toledo, F, Vieta, E, Gonzalez, E, Franco, M, Virgil Drasovean, N, Havard Dahl, N, Skagen, B, Zilles, D, Zwanzger, P, Juckel, G, Kahl, K, Messer, T, Kasper, S and Loxapine Inhaled Home Use Study In
Publicada:
1 oct 2018
Categoría:
Medicine (miscellaneous)
Resumen:
Introduction 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 (R)), 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.
Methods and analysis 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.
Ethics and dissemination 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.
Filiaciones:
Gil, E:
Ferrer Int SA, Dept Med, Barcelona, Spain
Garcia-Alonso, F:
Ferrer Int SA, Dept Med, Barcelona, Spain
Boldeanu, A:
Ferrer Int SA, Dept Med, Barcelona, Spain
Teixeira, T:
Ferrer Int SA, Dept Med, Barcelona, Spain
:
Hosp Lluis Alcanyis, Valencia, Spain
Palmer Viciedo, R:
Hosp Prov Castellon, Castellon de La Plana, Spain
Salgado, P:
Hosp del Mar, Barcelona, Spain
Domingo Ribas, J:
Inst NEPP, Barcelona, Spain
Corripio Collado, I:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Manuel Montes, J:
Hosp Ramon & Cajal, Madrid, Spain
Correas Lauffer, J:
Hosp Univ De Henares, Madrid, Spain
Ruiz Murugarrem, S:
Hosp Principe Asturias, Madrid, Spain
Ovejero Garcia, S:
Fdn Jimenez Diaz, Madrid, Spain
Mora, F:
Hosp Infanta Leonor, Madrid, Spain
Lopez, A:
Complejo Hosp Torrecardenas, Almeria, Spain
Fontalba Navas, A:
Hosp Inmaculada, Granada, Spain
Gonzalez Pinto, A:
Hosp Santiago Apostol, Milan, Italy
Martinez, R:
Hosp Virgen del Miron, Soria, Spain
Garcia Castrillo, C:
Complejo Hosp de Jaen, Jaen, Spain
Toledo, F:
Hosp Univ Virgen de Arrixaca, El Palmar, Spain
Vieta, E:
Hosp Clin Barcelona, Barcelona, Spain
Gonzalez, E:
Hermanas Hosp Sociosanitario Palencia, Palencia, Spain
Franco, M:
Complejo Asistencial Zamora, Zamora, Spain
Virgil Drasovean, N:
Spitalul Psihiatrie Elisabeta Doamna Galati, Galati, Spain
Havard Dahl, N:
Helse Nord Trondelag HV Sykehuset Levanger, Levanger, Norway
Skagen, B:
Straume Helsesenteret, Spesialistesenteret, Straume, Norway
Zilles, D:
Univ Med Gottingen, Klin Psychiat & Psychotherapie, Gottingen, Germany
Zwanzger, P:
Allgemeinpsychiat & Psychosomat, Munich, Germany
Juckel, G:
Ruhr Univ Bochum, LWL Univ Klinikum Bochum, Bochum, Germany
Kahl, K:
Hannover Med Sch, Hannover, Germany
Messer, T:
Fachklin Psychiat Psychotherapie & Psychosomat, Treuenbrietzen, Germany
Kasper, S:
Med Univ Wien, Univ Klinikum Psychiat & Psychotherapie, Vienna, Austria
Open Access
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