Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler.
Mometasone furoate (MF) administered by dry powder inhaler (DPI) was composed with budesonide (BUD) Turbuhaler in the treatment of moderate persistent asthma. The patients were randomized to one of four treatment groups: MF DPI (100, 200, 400 microg b.i.d) or BUD Turbuhaler. 400 microg b.i.d in a 12-week, active-controlled, evaluator-blind, multicentre international trial. The primary efficacy variable was the mean change from baseline to endpoint (last treatment visit) in forced expiratory volume in one second (FEV1). Changes in FEV1 showed a statistically significant superiority (p<0.05) of MF DPI 200 and 400 microg b.i.d compared with the BUD Turbuhaler 400 microg b.i.d treatment. Significant superiority (p<0.05) was also seen in scores for several secondary efficacy variables when MF DPI was compared with BUD Turbuhaler treatment. MF DPI 200 microg b.i.d was comparable to MF DPI 400 microg b.i.d in therapeutic benefit. The incidence of oral candidiasis was no more than 3% in any group. All treatments were well tolerated. A total daily dose of 400 microg of mometasone furoate administered by dry powder inhaler provides a well-tolerated treatment for patients with moderate persistent asthma and results in a significantly greater improvement, when compared to a daily dose of 800 microg BUD Turbuhaler in the parameters measured in this study.
Bousquet
J
J
H pital Arnaud de Villenueve, Service des Maladies Respiratoires, Montpellier, France.
D'Urzo
A
A
Hebert
J
J
Barraza
C H
CH
Boulet
L P
LP
Suárez-Chacón
R
R
Harnest
U
U
Lundbäck
B
B
Martinez Morales
G
G
Nieminen
M M
MM
Nolop
K B
KB
Visser
S
S
Lutsky
B N
BN
D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002940:Circadian Rhythm; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009330:Nebulizers and Vaporizers; D011208:Powders; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D016037:Single-Blind Method; D012890:Sleep / Q000187:drug effects; D013997:Time Factors
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D011208:Powders; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D019819:Budesonide; D000420:Albuterol