BACKGROUND: There is a need for a rapid-acting, non-injection, acute treatment for agitation. AIMS: To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia. METHOD: This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses ofinhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression-Improvement scale (CGI-I) score 2 h after dose one. RESULTS:Inhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS-EC score was evident 10 min after dose one with both 5 and 10 mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications. CONCLUSIONS:Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
RCT Entities:
BACKGROUND: There is a need for a rapid-acting, non-injection, acute treatment for agitation. AIMS: To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia. METHOD: This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression-Improvement scale (CGI-I) score 2 h after dose one. RESULTS: Inhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS-EC score was evident 10 min after dose one with both 5 and 10 mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications. CONCLUSIONS: Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
Authors: John Gar Yan Chan; Jennifer Wong; Qi Tony Zhou; Sharon Shui Yee Leung; Hak-Kim Chan Journal: AAPS PharmSciTech Date: 2014-04-12 Impact factor: 3.246
Authors: Jessica A Hellings; Gregory Reed; Sharon E Cain; Xinghua Zhou; Francis X Barth; Michael G Aman; Gladys I Palaguachi; Dmytro Mikhnev; Rujia Teng; Rebecca Andridge; Marilyn Logan; Merlin G Butler; Joan C Han Journal: J Child Adolesc Psychopharmacol Date: 2015-03 Impact factor: 2.576
Authors: Nicholas Gross; Leon S Greos; Eli O Meltzer; Selwyn Spangenthal; Robert S Fishman; Daniel A Spyker; James V Cassella Journal: J Aerosol Med Pulm Drug Deliv Date: 2014-12 Impact factor: 2.849