<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01671852</url>
  </required_header>
  <id_info>
    <org_study_id>H12-01653</org_study_id>
    <nct_id>NCT01671852</nct_id>
  </id_info>
  <brief_title>Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy</brief_title>
  <acronym>Nasonex OSA</acronym>
  <official_title>A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's &amp; Women's Health Centre of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's &amp; Women's Health Centre of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep&#xD;
      characterized by prolonged partial upper airway obstruction and/or intermittent complete&#xD;
      obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition&#xD;
      occurs in 2-5% of children and can occur at any age, but it is most common in children&#xD;
      between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease,&#xD;
      growth delay, poor learning and behavioral problems such as inattention and hyperactivity.&#xD;
      The most common underlying risk factor for the development of OSA is enlargement of tonsils&#xD;
      and adenoids. Given the potential risk of complications associated with surgery of the&#xD;
      tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been&#xD;
      considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent&#xD;
      Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to&#xD;
      moderate OSA4. The authors recommended that further randomised controlled studies were&#xD;
      required to evaluate the efficacy of INCSs in children with OSA. In particular they&#xD;
      recommended that future studies should employ sleep studies to look for any improvement with&#xD;
      INCSs, and should include children with more severe OSA, as these are the patients at the&#xD;
      greatest risk of complications of surgery and would benefit most from a non-surgical&#xD;
      treatment. The purpose of this study is therefore to explore the efficacy of INCSs in&#xD;
      children with the full spectrum of OSA severity, including sleep study analysis., and longer&#xD;
      term follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Could not obtain funding.&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea Hypopnea Index (AHI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>This wil be measured by polysomnography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory Disturbance Index</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Desaturation index</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory arousal index</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nadir of arterial oxygen saturation</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial oxygen saturation</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avoidance of surgical treatment for OSA</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.)</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])</measure>
    <time_frame>At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)</time_frame>
    <description>This will be measured by polysomnography.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography</condition>
  <arm_group>
    <arm_group_label>Nasonex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive saline nasal sprays for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mometasone furoate nasal spray</intervention_name>
    <description>Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.&#xD;
For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.</description>
    <arm_group_label>Nasonex</arm_group_label>
    <other_name>Nasonex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe)&#xD;
             as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed&#xD;
             apneas and obstructive hypopneas).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with malformation syndromes or craniofacial anomalies&#xD;
&#xD;
          -  Children with neuromuscular disorders&#xD;
&#xD;
          -  Children with morbid obesity (body mass index ≥ 40)&#xD;
&#xD;
          -  Children with asthma requiring steroid treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BC Women's and Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>July 28, 2015</last_update_submitted>
  <last_update_submitted_qc>July 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's &amp; Women's Health Centre of British Columbia</investigator_affiliation>
    <investigator_full_name>Neil Chadha</investigator_full_name>
    <investigator_title>Dr. Neil K. Chadha MBChB(Hons),MPHe BSc(Hons),FRCS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01671852
org study id: H12-01653
nct id: NCT01671852
lead sponsor: 
has dmc: No
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep
      characterized by prolonged partial upper airway obstruction and/or intermittent complete
      obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition
      occurs in 2-5% of children and can occur at any age, but it is most common in children
      between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease,
      growth delay, poor learning and behavioral problems such as inattention and hyperactivity.
      The most common underlying risk factor for the development of OSA is enlargement of tonsils
      and adenoids. Given the potential risk of complications associated with surgery of the
      tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been
      considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent
      Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to
      moderate OSA4. The authors recommended that further randomised controlled studies were
      required to evaluate the efficacy of INCSs in children with OSA. In particular they
      recommended that future studies should employ sleep studies to look for any improvement with
      INCSs, and should include children with more severe OSA, as these are the patients at the
      greatest risk of complications of surgery and would benefit most from a non-surgical
      treatment. The purpose of this study is therefore to explore the efficacy of INCSs in
      children with the full spectrum of OSA severity, including sleep study analysis., and longer
      term follow-up.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Apnea Hypopnea Index (AHI)
time frame: 8 weeks
description: This wil be measured by polysomnography.
measure: Respiratory Disturbance Index
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Desaturation index
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Respiratory arousal index
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Nadir of arterial oxygen saturation
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Mean arterial oxygen saturation
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Avoidance of surgical treatment for OSA
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.)
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
measure: Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])
time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
description: This will be measured by polysomnography.
arm group label: Nasonex
arm group type: Active Comparator
description: The intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.
arm group label: Saline
arm group type: Placebo Comparator
description: The placebo group will receive saline nasal sprays for 8 weeks.
intervention type: Drug
intervention name: Mometasone furoate nasal spray
description: Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.
For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.
arm group label: Nasonex
other name: Nasonex
intervention type: Drug
intervention name: Placebo
arm group label: Saline
criteria: 
gender: All
minimum age: 3 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Children's & Women's Health Centre of British Columbia
investigator full name: Neil Chadha
investigator title: Dr. Neil K. Chadha MBChB(Hons),MPHe BSc(Hons),FRCS
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypertrophy
mesh term: Mometasone Furoate