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The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)

Primary Purpose

Perennial Allergic Rhinitis, Obstructive Sleep Apnea, Sleep Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mometasone furoate nasal spray
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Hypopnea Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Demonstration of willingness to participate in the study and comply with its procedures by signing a written informed consent. Ages 18 to 60 years, of either sex, and of any race. A 2-year or longer history of perennial allergic rhinitis (PAR) with or without SAR. Skin test positive to a relevant prevalent perennial allergen or seasonal allergens if the subject also has SAR done either at the Screening Visit or within the previous 12 months. At the Screening Visit (Visit 1) subject must have TNSS of >=12 our of a possible 24, nasal congestion score of 4 out of a possible 6 on congestion, an Interference With Sleep average score of (2) moderate over 7 nights prior to the Screening Visit. At the Baseline Visit (Visit 2) scores, reflective over the previous 12 hours, of 4 or more for nasal congestion using a categorical whole-number symptom severity scale encompassing 7 severity ratings on at least 6 of the 15 recordings of the Run-in period which may include the morning of the Baseline Visit (Visit 2). At the Baseline Visit (Visit 2) subject must have a TNSS of more than >=12 out of a possible 24 reflective over the past 12 hours on at least 6 or more of the 15 recordings of the Run-in period, which may include the morning of the Baseline Visit. Current complaint of sleep disturbance while symptomatic with PAR and have a score of at least 2 with the Interference with Sleep scale on at least 4 out of the 8 AM diary recordings during the Run-in period and may include the morning of Visit 2 (Baseline). The number of AH events per hour will be recorded but should not exceed 30 per hour. Freedom from any clinically significant disease (other than PAR or SAR) that would interfere with the study evaluations. Confirmation by subject that he/she is practicing adequate contraception: Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening and while receiving protocol-specified medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Understanding of, and ability to adhere to, the dosing and visit schedules, and agreement to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary. Exclusion Criteria: Pregnant or intention to become pregnant during the study Breast-feeding or intention to breast-feed during the study or within 30 days after study completion Currently medication for PAR, or during the 10 days prior to the Screening Visit, treatment for SAR or PAR with an antihistamine or a nasal inhaled corticosteroid. Current or a history of frequent (2 or more episodes per year for the past 2 years) clinically significant sinusitis or chronic purulent postnasal drip. Recent nasal septum ulcers, nasal surgery, or nasal trauma; postpone inclusion until healing has occurred. A diagnosis of rhinitis medicamentosa. Upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to screening, or a viral upper or lower respiratory infection within 7 days prior to screening. Nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfere with nasal airflow. Bronchial asthma that cannot be controlled by short-acting beta 2-agonist adrenergic receptor agonists. Current desensitization immunotherapy and expectation of receiving an increase in dose during the study. Subject may not receive desensitization treatment within 24 hours prior to a study visit. Failure to observe the designated washout periods for any of the prohibited medications outlined in section 6.2 of the protocol. Previous randomization into the study. Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study, or the subject's ability to complete the diary cards. Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex. Compromised ability to provide informed consent. A history of non-compliance with medications or treatment protocols. Morbidly obese (BMI >= 40). Night-shift working schedule with no standard asleep at night/awake during the day cycle. Any clinically significant deviation from the appropriate reference range in the physical examination that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety. a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study. Participation in any other clinical study(ies). Subject is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. Subject is allergic to or has sensitivity to the study drug or its excipients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mometasone furoate nasal spray

    Placebo nasal spray

    Arm Description

    Outcomes

    Primary Outcome Measures

    Apnea-Hypopnea Index
    Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00359216
    Brief Title
    The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
    Official Title
    A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Sleep-disordered Breathing Associated With Perennial Allergic Rhinitis (PAR) Using Home-Monitored Cardio-Respiratory Methodology.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (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
    This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perennial Allergic Rhinitis, Obstructive Sleep Apnea, Sleep Disorder
    Keywords
    Hypopnea Syndrome

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Mometasone furoate nasal spray
    Arm Type
    Experimental
    Arm Title
    Placebo nasal spray
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone furoate nasal spray
    Other Intervention Name(s)
    Nasonex
    Intervention Description
    MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
    Primary Outcome Measure Information:
    Title
    Apnea-Hypopnea Index
    Description
    Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.
    Time Frame
    change from baseline (screening) at the end of 28 days of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Demonstration of willingness to participate in the study and comply with its procedures by signing a written informed consent. Ages 18 to 60 years, of either sex, and of any race. A 2-year or longer history of perennial allergic rhinitis (PAR) with or without SAR. Skin test positive to a relevant prevalent perennial allergen or seasonal allergens if the subject also has SAR done either at the Screening Visit or within the previous 12 months. At the Screening Visit (Visit 1) subject must have TNSS of >=12 our of a possible 24, nasal congestion score of 4 out of a possible 6 on congestion, an Interference With Sleep average score of (2) moderate over 7 nights prior to the Screening Visit. At the Baseline Visit (Visit 2) scores, reflective over the previous 12 hours, of 4 or more for nasal congestion using a categorical whole-number symptom severity scale encompassing 7 severity ratings on at least 6 of the 15 recordings of the Run-in period which may include the morning of the Baseline Visit (Visit 2). At the Baseline Visit (Visit 2) subject must have a TNSS of more than >=12 out of a possible 24 reflective over the past 12 hours on at least 6 or more of the 15 recordings of the Run-in period, which may include the morning of the Baseline Visit. Current complaint of sleep disturbance while symptomatic with PAR and have a score of at least 2 with the Interference with Sleep scale on at least 4 out of the 8 AM diary recordings during the Run-in period and may include the morning of Visit 2 (Baseline). The number of AH events per hour will be recorded but should not exceed 30 per hour. Freedom from any clinically significant disease (other than PAR or SAR) that would interfere with the study evaluations. Confirmation by subject that he/she is practicing adequate contraception: Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening and while receiving protocol-specified medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Understanding of, and ability to adhere to, the dosing and visit schedules, and agreement to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary. Exclusion Criteria: Pregnant or intention to become pregnant during the study Breast-feeding or intention to breast-feed during the study or within 30 days after study completion Currently medication for PAR, or during the 10 days prior to the Screening Visit, treatment for SAR or PAR with an antihistamine or a nasal inhaled corticosteroid. Current or a history of frequent (2 or more episodes per year for the past 2 years) clinically significant sinusitis or chronic purulent postnasal drip. Recent nasal septum ulcers, nasal surgery, or nasal trauma; postpone inclusion until healing has occurred. A diagnosis of rhinitis medicamentosa. Upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to screening, or a viral upper or lower respiratory infection within 7 days prior to screening. Nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfere with nasal airflow. Bronchial asthma that cannot be controlled by short-acting beta 2-agonist adrenergic receptor agonists. Current desensitization immunotherapy and expectation of receiving an increase in dose during the study. Subject may not receive desensitization treatment within 24 hours prior to a study visit. Failure to observe the designated washout periods for any of the prohibited medications outlined in section 6.2 of the protocol. Previous randomization into the study. Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study, or the subject's ability to complete the diary cards. Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex. Compromised ability to provide informed consent. A history of non-compliance with medications or treatment protocols. Morbidly obese (BMI >= 40). Night-shift working schedule with no standard asleep at night/awake during the day cycle. Any clinically significant deviation from the appropriate reference range in the physical examination that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety. a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study. Participation in any other clinical study(ies). Subject is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. Subject is allergic to or has sensitivity to the study drug or its excipients.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    20642206
    Citation
    Meltzer EO, Munafo DA, Chung W, Gopalan G, Varghese ST. Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep. Ann Allergy Asthma Immunol. 2010 Jul;105(1):65-74. doi: 10.1016/j.anai.2010.04.020.
    Results Reference
    result

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    The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)

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