This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
455
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2
Time frame: After 2 weeks of treatment
Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)
Time frame: After 1 and 2 weeks of treatment
Overall improvement
Time frame: After 1 and 2 weeks of treatment
QOL score
Time frame: At initial day of treatment and after 2 weeks of treatment
Adverse events
Time frame: From initial day of treatment until 7-10 days after treatment is stopped.
Laboratory tests
Time frame: From initial day of treatment until treatment is stopped.
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Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.