E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perennial Allergic Rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
Perennial Allergic Rhinitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to examine the safety of mometasone furoate nasal spray (MFNS) administered long-term (12 weeks to up to 24 weeks) to pediatric subjects with perennial allergic rhinitis
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E.2.2 | Secondary objectives of the trial |
The secondary objectives will include the assessment of (1) the efficacy of MFNS administered long-term (12 weeks to up to 24 weeks) as well as the assessment of (2) rebound phenomenon and (3) withdrawal symptoms after the end of treatment in pediatric subjects with perennial allergic rhinitis.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree. 2. Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen). 3. Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
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E.4 | Principal exclusion criteria |
1. Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration 2. Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics 3. Subjects with repeated epistaxis 4. Subjects with coexisting fungal infection in nasal/sinus cavity 5. Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray 6. Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor. 7. Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is safety. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The safety data was collected at each visit. Laboratory tests and urinalysis will be performed at 4, 12, and 24 weeks (or at completion/discontinuation) after treatment. Blood cortisol will be measured at 12 and 24 weeks (or at completion/discontinuation) of treatment to evaluate the effect of MF on the HPA axis. |
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints are the change in total nasal symptom scores, change in individual nasal symptom score (sneezing, rhinorrhea, nasal congestion, and nasal itching), change in individual nasal finding score (swelling of inferior nasal concha mucosa, coloring of inferior nasal concha mucosa, rhinorrhea discharged), change in interference with performance of daily activities score, and global improvement |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At weeks 2, 4, 8, 12, 16, 20, 24 (completion/discontinuation), and at follow-up (at the follow-up, only nasal symptoms and nasal findings will be assessed). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |