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| ID | Type | Description | Link |
|---|---|---|---|
| JPC-03-342-20 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo group was divided into 3 groups receiving 1, 2 or 4 sprays/nostril. The regimen of each placebo group was BID |
|
| Mometasone furoate nasal spray 100 mcg QD | Experimental |
| |
| Mometasone furoate nasal spray 200 mcg QD | Experimental |
| |
| Mometasone furoate nasal spray 400 mcg QD | Experimental |
| |
| Mometasone furoate nasal spray 100 mcg BID | Experimental |
| |
| Mometasone furoate nasal spray 200 mcg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not included in the present study:
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Mometasone furoate | Drug | 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. |
|
|
| Mometasone furoate | Drug | 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. |
|
|
| Mometasone furoate | Drug | 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. |
|
|
| Mometasone furoate | Drug | 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. |
|
|
| Mometasone furoate | Drug | 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. |
|
|
| 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |