Effects of treatment with mometasone furoate dry powder inhaler in children with persistent asthma.
BACKGROUND
Mometasone furoate dry powder inhaler (DPI) has been shown to effectively treat asthma in children.


OBJECTIVE
To evaluate the efficacy and safety of 2 dosing regimens of mometasone furoate DPI in the treatment of mild-to-moderate persistent asthma in children previously using inhaled corticosteroids (ICSs).


METHODS
A 12-week, multicenter, double-blind, parallel-group, placebo-controlled study evaluated 2 dosing regimens of mometasone furoate DPI (100 microg every evening and 100 microg twice daily) in 296 children 4 to 11 years old with asthma previously using ICSs. The primary efficacy variable was the change in percentage of predicted forced expiratory volume in 1 second (FEV1) from baseline to end point. Secondary efficacy variables included absolute FEV1, forced expiratory flow between 25% and 75% forced vital capacity, morning and evening peak expiratory flow, asthma symptom scores, albuterol use, nocturnal awakenings, response to therapy, and health-related quality of life.


RESULTS
Mean changes from baseline at end point in predicted FEV1 were 4.73 and 5.52 percentage points for mometasone furoate DPI, 100 microg every evening and 100 microg twice daily, respectively, the difference of which was not significant, and -1.77 percentage points for placebo (P < or = .002). Significant improvements in secondary efficacy variables were also observed for both mometasone furoate DPI treatments over placebo. Both mometasone furoate DPI doses were well tolerated, and no significant differences were noted among the 3 treatment groups in adverse event reporting.


CONCLUSIONS
Both mometasone furoate DPI doses were well tolerated and significantly improved lung function, maintained effective asthma control, and improved quality of life in children with asthma.
Berger
William E
WE
Allergy and Asthma Associates, Mission Viejo, California 92691, USA. WEBerger@uci.edu
Milgrom
Henry
H
Chervinsky
Paul
P
Noonan
Michael
M
Weinstein
Steven F
SF
Lutsky
Barry N
BN
Staudinger
Heribert
H
D015746:Abdominal Pain / Q000139:chemically induced; D000280:Administration, Inhalation; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D000068656:Mometasone Furoate; D011208:Powders; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012129:Respiratory Function Tests; D013147:Spirometry; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D011208:Powders; D011244:Pregnadienediols; D000068656:Mometasone Furoate