A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis.
BACKGROUND
Intranasal corticosteroids and oral antihistamines are both effective in the treatment of seasonal allergic rhinitis, although the therapeutic value of administering the two types of agents concurrently has rarely been evaluated. This study was designed to compared the efficacy, safety, and impact on quality of life of fluticasone propionate aqueous nasal spray (FP ANS), loratadine, FP ANS plus loratadine, and placebo (an aqueous nasal spray plus tablet) in the treatment of seasonal allergic rhinitis during the mountain cedar allergy season in south central Texas.


METHODS
Six hundred patients with seasonal allergic rhinitis were treated for 2 weeks with either FP ANS 200 microgram once daily, loratadine 10 mg once daily, the FP ANS and loratadine regimens combined, or placebo in a multicenter, randomized, double-blind, double-dummy, parallel-group study.


RESULTS
Clinician- and patient-rated total and individual nasal symptom scores after 7 and 14 days of therapy and overall evaluations were significantly lower (P < .001) in the FP ANS and FP ANS plus loratadine groups compared with the loratadine only and placebo groups. Loratadine was not statistically different from placebo in clinician and patient symptom score ratings nor in overall clinician and patient evaluations. FP ANS plus loratadine and FP ANS monotherapy were comparable in efficacy in almost all evaluations; for some patient-rated symptoms the combination was found superior. Mean score changes in the Rhinoconjunctivitis Quality of Life Questionnaire from baseline to day 14 showed significantly greater improvement (P < .001) in quality of life in the FP ANS group than in the group of patients receiving loratadine only or placebo and no significant benefit was demonstrated in the FP ANS plus loratadine group over the FP ANS monotherapy group. No serious or unusual drug-related adverse events were reported. Combining loratadine with FP ANS did not alter the adverse events profile or frequency.
Sylvana Research, San Antonio, Texas 78229, USA.
P H
PH
Ratner
J H
JH
van Bavel
B G
BG
Martin
F C
FC
Hampel
W C
WC
Howland
P R
PR
Rogenes
R E
RE
Westlund
B W
BW
Bowers
C K
CK
Cook
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000276:immunology; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000276:immunology; D013781:Texas
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D006634:Histamine H1 Antagonists; D017336:Loratadine; D000068298:Fluticasone