Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Rhinitis, Allergic

Intervention / Treatment
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* Drug: Mometasone furoate nasal spray (MFNS)
* Drug: Loratadine
* Drug: Placebo nasal spray
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFNS 200 µg + Loratadine 10 mg<br>Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet. | Drug: Mometasone furoate nasal spray (MFNS)<br>* Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.<br>* Other names: NASONEX®;Drug: Loratadine<br>* Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.<br>* Other names: Claritin®;|
| Active Comparator: MFNS 200 µg<br>Daily administration of 200 µg of MFNS plus oral placebo tablet. | Drug: Mometasone furoate nasal spray (MFNS)<br>* Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.<br>* Other names: NASONEX®;Drug: Placebo tablet<br>* Daily dose of placebo administered as an oral tablet for 15 days.<br>|
| Active Comparator: Loratadine 10 mg<br>Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. | Drug: Loratadine<br>* Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.<br>* Other names: Claritin®;Drug: Placebo nasal spray<br>* Daily dose of placebo administered as a nasal spray for 15 days.<br>|
| Placebo Comparator: Placebo<br>Daily administration of placebo nasal spray plus oral placebo tablet. | Drug: Placebo nasal spray<br>* Daily dose of placebo administered as a nasal spray for 15 days.<br>Drug: Placebo tablet<br>* Daily dose of placebo administered as an oral tablet for 15 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment. | Baseline and days 1 through 15 (average of 15 days of treatment) | 
| Change From Baseline in Total Symptom Score (Assessed by Participant) | Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment. | Baseline and days 1 through 15 (average of 15 days of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) | The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 15 | 
| Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) | The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 15 | 
| Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) | The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 8 | 
| Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) | The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 8 | 
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) | The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 15 | 
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) | The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. | Baseline and study day 8 | 
| Response to Therapy on Day 15 (Assessed by Physician) | Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response. | Study day 15 | 
| Response to Therapy on Day 8 (Assessed by Physician) | Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response. | Study day 8 |