Phase 3 Completed N=201 Randomized Triple-blind Treatment

Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

Rhinitis, Allergic, Seasonal

Source: ClinicalTrials.gov NCT03861559 ↗

Enrolled (actual)

201

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcomePrimary: Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses — 35.9; 72.0 Hours — p=<0.01

◆ 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 This can indicate results are unpublished — a known publication-bias signal.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

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses	35.9; 72.0	<0.01 sig
SECONDARY Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant	-39; -20	<0.01 sig
SECONDARY Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator	-34; -16	<0.01 sig
SECONDARY Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator	-44; -28	<0.01 sig
SECONDARY Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator	-43; -27	<0.01 sig
SECONDARY Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator	-22; -16	0.14
SECONDARY Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator	-34; -22	0.02 sig
SECONDARY Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator	-41; -18	<0.01 sig
SECONDARY Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant	-24; -18	0.15
SECONDARY Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant	-36; -21	<0.01 sig
SECONDARY Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant	-41; -21	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 4 as Assessed by Investigator	3.2; 3.8	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 8 as Assessed by Investigator	2.9; 3.5	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 15 as Assessed by Investigator	2.7; 3.7	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 4 as Assessed by Participant	3.2; 3.8	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 8 as Assessed by Participant	2.9; 3.6	<0.01 sig
SECONDARY Therapeutic Response to Treatment at Day 15 as Assessed by Participant	2.8; 3.6	<0.01 sig

Eligibility Criteria

Inclusion Criteria

Has a 2-year history of seasonal allergic rhinitis
Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
Is on immunotherapy with the exception of maintenance therapy
Has a clinically significant upper respiratory or sinus infection
Has used an investigational drug within the previous 30 days
Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
Has rhinitis medicamentosa
Is using of any chronic medication which could affect the course of seasonal allergic rhinitis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03861559). 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.