Rhinitis, Allergic, Perennial
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
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.
DRUGMometasone furoate
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.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of mongoloid race residing in Japan who satisfy all of the following criteria: * Patients having symptoms of allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining the informed consent during the pretreatment observation period. * Patients in whom the skin or specific IgE test is positive and the cytological examination for eosinophils in nasal discharge or nasal challenge test is positive. * Out-patients aged 16 years or over at the time of obtaining the informed consent. * Male or female. * Patients from whom the informed consent can be obtained in writing (or the informed consent can be obtained from the patient's legally acceptable representative, if under 20 years). * Patients who can daily complete the nasal allergy diary.
Exclusion criteria
* Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2 | After 2 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) | After 1 and 2 weeks of treatment |
| Overall improvement | After 1 and 2 weeks of treatment |
| QOL score | At initial day of treatment and after 2 weeks of treatment |
| Adverse events | From initial day of treatment until 7-10 days after treatment is stopped. |
| Laboratory tests | From initial day of treatment until treatment is stopped. |
Outcome results
None listed