Clinical trial NCT03855228: Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
Official title: Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 704
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* 2-year history of seasonal allergic rhinitis
* Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
* 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
* Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
* Use of any chronic medication which could affect the course of seasonal allergic rhinitis
* Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
* Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
* Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
* Has rhinitis medicamentosa
* Evidence of clinically significant nasal candidiasis
* Investigational drug use within the previous 30 days
* Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
* Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
* History of multiple drug allergies, allergy to antihistamines or corticoids
* History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
timeFrame: Baseline and days 1 through 15 (average of 15 days of treatment)
measure: Change From Baseline in Total Symptom Score (Assessed by Participant)
timeFrame: Baseline and days 1 through 15 (average of 15 days of treatment)
Secondary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
timeFrame: Baseline and study day 15
measure: Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
timeFrame: Baseline and study day 15
measure: Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
timeFrame: Baseline and study day 8
measure: Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
timeFrame: Baseline and study day 8
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
timeFrame: Baseline and study day 15
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
timeFrame: Baseline and study day 8
measure: Response to Therapy on Day 15 (Assessed by Physician)
timeFrame: Study day 15
measure: Response to Therapy on Day 8 (Assessed by Physician)
timeFrame: Study day 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: