PMID- 19921960
OWN - NLM
STAT- MEDLINE
DCOM- 20100305
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 1
DP  - 2010 Jan
TI  - Efficacy, safety, and tolerability of mometasone furoate in adult Japanese 
      patients with mild asthma: open-label clinical trial findings.
PG  - 203-12
LID - 10.1185/03007990903422380 [doi]
AB  - OBJECTIVE: To evaluate the clinical efficacy and safety of mometasone furoate 
      administered via a dry powder inhaler (MF-DPI) in Japanese patients with 
      intermittent or mild persistent asthma who were not previously receiving inhaled 
      corticosteroids. RESEARCH DESIGN AND METHODS: This was an 8-week open-label study 
      conducted in Japanese patients > or =16 years of age with intermittent or mild 
      persistent asthma. All patients provided informed written consent before baseline 
      and were treated with MF-DPI 200 microg/day, taken as 100 microg twice daily 
      (BID). Inhaled steroids other than the study drug are not used, the drugs used 
      previously are continued, dose of concomitant drug may be reduced if symptoms are 
      improved and no new drugs were allowed during the trial. The primary efficacy 
      variable was the change from baseline in morning peak expiratory flow (AM PEF). 
      Secondary efficacy variables were evening (PM) PEF, spirometric measurements of 
      lung function, and subjective symptoms. Descriptive statistics and standard 
      errors were calculated for each efficacy evaluation. The safety of MF-DPI 
      treatment was evaluated by measuring adverse events (AEs) and laboratory tests. 
      RESULTS: Twenty patients received MF-DPI, and 19 patients (nine with intermittent 
      asthma and 10 with mild persistent asthma) were included in the full analysis set 
      (FAS). The mean AM PEF and PM PEF values increased by 9.1% (P < 0.0001) and 7.3% 
      (P < 0.0001), respectively, in the FAS. Improvements in AM and PM PEF occurred as 
      early as week 1 and were sustained throughout treatment. Improvements at week 8 
      in forced expiratory volume in 1 second and forced vital capacity were 11.0% and 
      8.2%, respectively. Notable decreases occurred for subjective symptom scores. The 
      reported AEs were mild to moderate in severity. Study limitations include the 
      small sample size and open-label treatment. This study was planned as the first 
      study of MF-DPI in Japanese mild asthma patients without receiving other inhaled 
      steroids. In addition, the cost:benefit ratio of MF-DPI in patients with 
      intermittent asthma was not addressed. CONCLUSION: MF-DPI 100 microg BID is an 
      effective treatment for Japanese patients with intermittent or mild persistent 
      asthma.
FAU - Tohda, Yuji
AU  - Tohda Y
AD  - Department of Respiratory Medicine and Allergology, Kinki University School of 
      Medicine, Osaka-Sayama City, Japan. tohda@med.kindai.ac.jp
FAU - Miyamoto, Terumasa
AU  - Miyamoto T
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Pregnadienediols)
RN  - 04201GDN4R (Mometasone Furoate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/adverse effects/*therapeutic use
MH  - Asthma/*drug therapy/physiopathology
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Mometasone Furoate
MH  - Patient Compliance
MH  - Peak Expiratory Flow Rate
MH  - Pregnadienediols/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/11/20 06:00
MHDA- 2010/03/06 06:00
CRDT- 2009/11/20 06:00
PHST- 2009/11/20 06:00 [entrez]
PHST- 2009/11/20 06:00 [pubmed]
PHST- 2010/03/06 06:00 [medline]
AID - 10.1185/03007990903422380 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 Jan;26(1):203-12. doi: 10.1185/03007990903422380.