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

Organon and Co201 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

201

Conditions

Rhinitis, Allergic, Seasonal

Interventions

mometasone furoate nasal sprayDRUG

intranasal administration

placebo nasal sprayDRUG

intranasal administration

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses

Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.

Time frame: From the start of treatment until onset of symptom relief (up to Day 4)

Secondary Outcomes

Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant

CFB, averaged over study days 1-15, was calculated for TNSS assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. A decrease in symptom severity is reflected by a negative CFB. Percent CFB was calculated as the difference between the baseline and 15-day average scores divided by baseline score multiplied by 100. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores were 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 was an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)

Data from ClinicalTrials.gov

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Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator

CFB on study Day 4 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 4, on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator

CFB on study Day 8 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator

CFB at Day 15 was calculated for TNSS assessed by the investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and endpoint scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator

CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator

CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator

CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant

CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant

CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant

CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 15

Therapeutic Response to Treatment at Day 4 as Assessed by Investigator

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 4. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.

Time frame: Day 4

Therapeutic Response to Treatment at Day 8 as Assessed by Investigator

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 8. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.

Time frame: Day 8

Therapeutic Response to Treatment at Day 15 as Assessed by Investigator

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 15. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Therapeutic Response to Treatment at Day 4 as Assessed by Participant

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 4. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.

Time frame: Day 4

Therapeutic Response to Treatment at Day 8 as Assessed by Participant

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 8. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.

Time frame: Day 8

Therapeutic Response to Treatment at Day 15 as Assessed by Participant

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 15. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.

Time frame: Day 15