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Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray (MFNS)
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be >=18 years of age and older, of either sex, and of any race. Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) Must have a 2-year or longer history of SAR occurring during the same season as the current study. Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit Must be free of clinically significant disease that would interfere with study evaluations Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation. Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit. Exclusion Criteria: Women who are pregnant, intend to become pregnant during the study, or are nursing Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants Acute respiratory infection within 2 weeks of the Screening Visit Diagnosis of clinically relevant sleep problems unassociated with allergies Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints Snoring associated with an enlarged uvula or other upper airway pathology Had episodes of snoring associated with gasping or choking Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems Diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting beta-2 adrenoceptor agonists Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids. Currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit and who wish to remain on this schedule during the study are eligible for study inclusion; however, they may not receive hyposensitization treatment within 24 hours prior to any study visit Smokers or ex-smokers who have smoked within the previous 6 months Concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders. Any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. Subjects participating in any other clinical study(ies). Subjects allergic to or with a sensitivity to the study drug or its excipients. Subjects who are night-shift workers or do not have a standard "asleep at night/awake during the day" cycle

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mometasone Furoate Nasal Spray

    Matching placebo nasal spray

    Arm Description

    Mometasone Furoate Nasal Spray 200 mcg, once daily.

    Outcomes

    Primary Outcome Measures

    Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.
    The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
    Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.
    Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2006
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
    Collaborators
    Integrated Therapeutics Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00358527
    Brief Title
    Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)
    Official Title
    A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Multicenter Study of Mometasone Furoate Nasal Spray on Sleep Disturbances and Daytime Somnolence in Subjects With Symptomatic Seasonal Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    Integrated Therapeutics Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seasonal Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    401 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mometasone Furoate Nasal Spray
    Arm Type
    Experimental
    Arm Description
    Mometasone Furoate Nasal Spray 200 mcg, once daily.
    Arm Title
    Matching placebo nasal spray
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate Nasal Spray (MFNS)
    Other Intervention Name(s)
    MFNS
    Intervention Description
    MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days
    Primary Outcome Measure Information:
    Title
    Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.
    Description
    The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
    Time Frame
    Average of the last 7 days of treatment
    Title
    Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.
    Description
    Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
    Time Frame
    29 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be >=18 years of age and older, of either sex, and of any race. Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) Must have a 2-year or longer history of SAR occurring during the same season as the current study. Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit Must be free of clinically significant disease that would interfere with study evaluations Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation. Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit. Exclusion Criteria: Women who are pregnant, intend to become pregnant during the study, or are nursing Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants Acute respiratory infection within 2 weeks of the Screening Visit Diagnosis of clinically relevant sleep problems unassociated with allergies Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints Snoring associated with an enlarged uvula or other upper airway pathology Had episodes of snoring associated with gasping or choking Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems Diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting beta-2 adrenoceptor agonists Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids. Currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit and who wish to remain on this schedule during the study are eligible for study inclusion; however, they may not receive hyposensitization treatment within 24 hours prior to any study visit Smokers or ex-smokers who have smoked within the previous 6 months Concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders. Any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. Subjects participating in any other clinical study(ies). Subjects allergic to or with a sensitivity to the study drug or its excipients. Subjects who are night-shift workers or do not have a standard "asleep at night/awake during the day" cycle

    12. IPD Sharing Statement

    Learn more about this trial

    Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)

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