Back to resultsSafety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
Primary Purpose
Rhinitis, Allergic
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone furoate nasal spray (MFNS)
Loratadine
Placebo nasal spray
Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
MFNS 200 µg + Loratadine 10 mg
MFNS 200 µg
Loratadine 10 mg
Placebo
Arm Description
Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 µg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03855228
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 1995 (Actual)
Primary Completion Date
August 7, 1995 (Actual)
Study Completion Date
August 7, 1995 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
704 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MFNS 200 µg + Loratadine 10 mg
Arm Type
Experimental
Arm Description
Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
Arm Title
MFNS 200 µg
Arm Type
Active Comparator
Arm Description
Daily administration of 200 µg of MFNS plus oral placebo tablet.
Arm Title
Loratadine 10 mg
Arm Type
Active Comparator
Arm Description
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily administration of placebo nasal spray plus oral placebo tablet.
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate nasal spray (MFNS)
Other Intervention Name(s)
SCH 32088, MK-0887, NASONEX®
Intervention Description
Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
Intervention Type
Drug
Intervention Name(s)
Loratadine
Other Intervention Name(s)
Claritin®
Intervention Description
Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Intervention Description
Daily dose of placebo administered as a nasal spray for 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Daily dose of placebo administered as an oral tablet for 15 days.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Description
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.
Time Frame
Baseline and days 1 through 15 (average of 15 days of treatment)
Title
Change From Baseline in Total Symptom Score (Assessed by Participant)
Description
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.
Time Frame
Baseline and days 1 through 15 (average of 15 days of treatment)
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 15
Title
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 15
Title
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 8
Title
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 8
Title
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 15
Title
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
Description
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.
Time Frame
Baseline and study day 8
Title
Response to Therapy on Day 15 (Assessed by Physician)
Description
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.
Time Frame
Study day 15
Title
Response to Therapy on Day 8 (Assessed by Physician)
Description
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.
Time Frame
Study day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
We'll reach out to this number within 24 hrs