Once daily mometasone furoate aqueous nasal spray is as effective as twice daily beclomethasone dipropionate for treating perennial allergic rhinitis patients.
BACKGROUND
Perennial allergic rhinitis is chronic and persistent, may lead to a constellation of secondary complaints including sinusitis, mouth-breathing, and some symptoms resembling a permanent cold, and often requires constant medical intervention. Well-tolerated nasal corticosteroids, alone or in combination with antihistamines, have been found to be very effective in treating this condition.


OBJECTIVE
To compare the effectiveness and tolerability of mometasone furoate aqueous suspension, a new once daily nasal spray, to placebo vehicle and to beclomethasone dipropionate, administered twice daily, in patients with perennial allergic rhinitis.


METHODS
This was a randomized, double-blind, placebo-controlled, double-dummy, parallel group study, in 427 patients age 12 years and older at 24 centers in Canada and Europe. Patients allergic to at least one perennial allergen, confirmed by medical history, skin testing, and adequate symptomatology were eligible to receive one of the following regimens for 3 months: mometasone furoate, 200 micrograms only daily; beclomethasone dipropionate, 200 micrograms twice daily (400 micrograms total dose); or placebo vehicle control. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.


RESULTS
Three hundred eighty-seven patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < or = .01) more effective than placebo and was indistinguishable from beclomethasone dipropionate. Similar trends were seen among individual symptoms, physician symptom evaluations, and therapeutic response. There was no evidence of tachyphylaxis. All treatments were well tolerated.


CONCLUSIONS
Mometasone furoate nasal spray adequately controls symptoms of perennial allergic rhinitis, offers the advantage of once daily treatment, and is well tolerated.
Drouin
M
M
Allergy and Asthma Research Centre, Ottawa, Ontario, Canada.
Yang
W H
WH
Bertrand
B
B
Van Cauwenberge
P
P
Clement
P
P
Dalby
K
K
Darnell
R
R
Ernst
T M
TM
Hébert
J
J
Karlsson
G
G
Luciuk
G
G
Mazza
J
J
Roovers
M
M
Ruoppi
P
P
Seppey
M
M
Stern
M
M
Suonpää
J
J
Sussman
G
G
Tan
K Y
KY
Tse
K
K
Widjaja
P
P
Jensen
P
P
Nolop
K
K
Lutsky
B N
BN
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D002940:Circadian Rhythm; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use; D008297:Male; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000627:therapeutic use; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D017336:Loratadine; D001507:Beclomethasone