Phase 3
Completed N=679
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT03879772 ↗
Enrolled (actual)
679
Serious AEs
0.3%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator — 7.8; 8.1; 7.9; 8.0 Scores on a scale — p=0.95
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator |
7.8; 8.1; 7.9; 8.0; 8.0; -2.8 | 0.95 |
| SECONDARY Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator |
7.8; 8.1; 7.9; 8.0; 8.0; -2.2 | 0.56 |
| SECONDARY Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator |
7.8; 8.1; 7.9; 8.0; 8.0; -2.9 | 0.8 |
| SECONDARY Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator |
7.8; 8.1; 7.9; 8.0; 8.0; -3.1 | 0.03 sig |
| SECONDARY Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant |
6.3; 6.9; 6.9; 6.6; 6.8; -1.5 | 0.16 |
| SECONDARY Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant |
6.3; 6.9; 6.9; 6.6; 6.8; -2.1 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
- Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
- Must be free of any clinically significant disease other than seasonal allergic rhinitis.
- Must be pre-menarcheal.
Exclusion Criteria
- History of asthma which requires chronic use of inhaled or systemic corticosteroids.
- Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- History of rhinitis medicamentosa.
- History of clinically significant nasal candidiasis.
- History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
- History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
- History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
- History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
- History of investigational drug use in the last 30 days.
- History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.
Data sourced from ClinicalTrials.gov (NCT03879772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.