This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate \[MF\] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 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 2 weeks of treatment
Overall improvement
Time frame: 2 weeks
Adverse events
Time frame: From initial day of treatment until treatment is stopped.
Laboratory tests
Time frame: At 7 or more days before treatment start, and after 2 weeks of treatment
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