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)

Study Overview
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Brief Summary
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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.

Official Title
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Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: Mometasone furoate nasal spray
* Drug: Beclomethasone dipropionate nasal spray
* Drug: Placebo nasal spray
* Drug: Chlorpheniramine maleate syrup


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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 25 mcg QD<br>Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | Drug: Mometasone furoate nasal spray<br>* intranasal administration<br>* Other names: SCH 032088;Drug: Placebo nasal spray<br>* intranasal administration<br>Drug: Chlorpheniramine maleate syrup<br>* oral administration<br>* Other names: ChlorTrimeton Syrup;|
| Experimental: MFNS 100 mcg QD<br>Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | Drug: Mometasone furoate nasal spray<br>* intranasal administration<br>* Other names: SCH 032088;Drug: Placebo nasal spray<br>* intranasal administration<br>Drug: Chlorpheniramine maleate syrup<br>* oral administration<br>* Other names: ChlorTrimeton Syrup;|
| Experimental: MFNS 200 mcg QD<br>Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | Drug: Mometasone furoate nasal spray<br>* intranasal administration<br>* Other names: SCH 032088;Drug: Placebo nasal spray<br>* intranasal administration<br>Drug: Chlorpheniramine maleate syrup<br>* oral administration<br>* Other names: ChlorTrimeton Syrup;|
| Active Comparator: BDP 84 mcg BID<br>Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | Drug: Beclomethasone dipropionate nasal spray<br>* intranasal administration<br>* Other names: Vancenase®;Drug: Chlorpheniramine maleate syrup<br>* oral administration<br>* Other names: ChlorTrimeton Syrup;|
| Placebo Comparator: Placebo<br>Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | Drug: Placebo nasal spray<br>* intranasal administration<br>Drug: Chlorpheniramine maleate syrup<br>* oral administration<br>* Other names: ChlorTrimeton Syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. | Baseline (Day 1) and Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. | Baseline (Day 1) and Day 4 | 
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. | Baseline (Day 1) and Day 15 | 
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. | Baseline (Day 1) and Day 29 | 
| 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 | Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain 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 were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. | Baseline and Days 1 through 15 (average over 15 days) | 
| 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 | Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain 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 were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. | Baseline and Days 16 through 29 (average over 15 days) |