A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis

• Conditions: Perennial Allergic Rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004922-16-Outside-EU/EEA
• Lead Sponsor: Corporation Schering-Plough K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-24
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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<br>;Secondary Objective: 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.<br>;Primary end point(s): The primary endpoint of the study is safety.;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.

Secondary Outcome Measures

Name	Time	Method
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;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).