PMID- 24745666
OWN - NLM
STAT- MEDLINE
DCOM- 20150921
LR  - 20211021
IS  - 1941-2703 (Electronic)
IS  - 1941-2711 (Print)
IS  - 1941-2711 (Linking)
VI  - 27
IP  - 6
DP  - 2014 Dec
TI  - Safety and tolerability of inhaled loxapine in subjects with asthma and chronic 
      obstructive pulmonary disease--two randomized controlled trials.
PG  - 478-87
LID - 10.1089/jamp.2013.1114 [doi]
AB  - BACKGROUND: Loxapine, a first-generation antipsychotic, delivered with a novel 
      inhalation delivery device developed for the acute treatment of agitation in 
      patients with schizophrenia or bipolar disorder was evaluated in subjects with 
      asthma or chronic obstructive pulmonary disease (COPD). METHODS: Separate 
      randomized, double-blind, parallel-arm, placebo-controlled trials compared two 
      administrations of inhaled loxapine (10 mg) 10 hr apart with placebo in 52 
      subjects with asthma and in 53 subjects with COPD. A thermally-generated drug 
      aerosol of loxapine was delivered to the deep lung for rapid systemic absorption. 
      Controller medications were continued throughout the study, but quick-relief 
      bronchodilators were withheld from 6-8 hr before through 34 hr after dose 1, 
      unless indicated as rescue. RESULTS: All airway adverse events (AEs) were of mild 
      or moderate severity. Symptomatic bronchospasm occurred in 53.8% of subjects with 
      asthma after inhaled loxapine and 11.5% after placebo; and in 19.2% of COPD 
      subjects after inhaled loxapine and 11.1% after placebo. Subjects required 
      inhaled albuterol as follows: asthma: 53.8% after inhaled loxapine and 11.5% 
      after placebo; and COPD: 23.1% after inhaled loxapine and 14.8% after placebo. 
      Respiratory signs/symptoms requiring treatment responded to rescue bronchodilator 
      [forced expiratory volume in 1 sec (FEV(1)) return to within 10% of baseline] 
      within 1 hr in 11 of 15 events in asthma subjects and four of seven events in 
      COPD subjects, the remainder by the last spirometry. CONCLUSIONS: In subjects 
      with either asthma or COPD, FEV(1) decline and bronchospasm can occur following 
      inhaled loxapine, but more frequently in asthmatic subjects. Most subjects with 
      bronchospasm responded to rescue bronchodilator within 1 hr. No treatment-related 
      serious AE occurred. Although inhaled loxapine is contraindicated in patients 
      with active airways disease per the current approved US labeling, these studies 
      demonstrated that rescue bronchodilator mitigated the symptomatic bronchospasms 
      that may occur in case of inadvertent use.
FAU - Gross, Nicholas
AU  - Gross N
AD  - 1 St. Francis Hospital, Hartford CT, and University Medical Research , 
      Farmington, CT.
FAU - Greos, Leon S
AU  - Greos LS
FAU - Meltzer, Eli O
AU  - Meltzer EO
FAU - Spangenthal, Selwyn
AU  - Spangenthal S
FAU - Fishman, Robert S
AU  - Fishman RS
FAU - Spyker, Daniel A
AU  - Spyker DA
FAU - Cassella, James V
AU  - Cassella JV
LA  - eng
SI  - ClinicalTrials.gov/NCT00889837
SI  - ClinicalTrials.gov/NCT00890175
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Aerosol Med Pulm Drug Deliv
JT  - Journal of aerosol medicine and pulmonary drug delivery
JID - 101475057
RN  - 0 (Aerosols)
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Respiratory System Agents)
RN  - LER583670J (Loxapine)
RN  - QF8SVZ843E (Albuterol)
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adult
MH  - Aerosols
MH  - Aged
MH  - Albuterol/administration & dosage
MH  - Antipsychotic Agents/*administration & dosage/adverse effects
MH  - Asthma/diagnosis/*drug therapy/physiopathology
MH  - Bronchial Spasm/chemically induced/drug therapy/physiopathology
MH  - Bronchodilator Agents/administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Loxapine/*administration & dosage/adverse effects
MH  - Lung/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/diagnosis/*drug therapy/physiopathology
MH  - Respiratory System Agents/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Young Adult
PMC - PMC4273199
OTO - NOTNLM
OT  - ADASUVE
OT  - COPD
OT  - aerosol
OT  - agitation
OT  - asthma
OT  - inhaled loxapine
OT  - randomized
OT  - safety
EDAT- 2014/04/22 06:00
MHDA- 2015/09/22 06:00
PMCR- 2014/12/01
CRDT- 2014/04/22 06:00
PHST- 2014/04/22 06:00 [entrez]
PHST- 2014/04/22 06:00 [pubmed]
PHST- 2015/09/22 06:00 [medline]
PHST- 2014/12/01 00:00 [pmc-release]
AID - 10.1089/jamp.2013.1114 [pii]
AID - 10.1089/jamp.2013.1114 [doi]
PST - ppublish
SO  - J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):478-87. doi: 
      10.1089/jamp.2013.1114.