<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/NCT03752645</url>
  </required_header>
  <id_info>
    <org_study_id>CF18014A#1</org_study_id>
    <nct_id>NCT03752645</nct_id>
  </id_info>
  <brief_title>Subjects With Clinical Diagnosis of Allergic Rhinitis Were Randomly Divided Into 2 Groups, With Patients in One Group Given One Treatment Session of Red Light Rhinophototherapy, Followed by Medical Treatment. Those in the Second Group Were Treated With Medical Treatment Only.</brief_title>
  <official_title>Effect of Red Light Rhinophototherapy on Nasal Patency in Patients With Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the short-term effects of red light rhinophototherapy on nasal patency in&#xD;
      patients with a clinical diagnosis of allergic rhinitis using both active anterior&#xD;
      rhinomanometry and acoustic rhinometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients experiencing moderate to severe symptoms of allergic rhinitis (AR)were collected.&#xD;
      The clinical diagnosis of AR was established when patients presented themselves with a&#xD;
      history and physical examination consistent with an allergic cause. Each candidate possessed&#xD;
      at least one of the following symptoms: nasal congestion, runny nose, itchy nose, or&#xD;
      sneezing. All patients underwent a specific IgE test against the common perennial inhaled&#xD;
      allergens found in Taiwan (house dust mites, molds, cats, dogs and cockroaches) to confirm&#xD;
      the diagnosis of AR. However, these results did not exclude the patients from this study&#xD;
      because only a few allergens were tested. The severity of the rhinitis symptoms was assessed&#xD;
      through use of a standardized score scale (1). A score of 0 (no symptoms), 1 (mild symptoms),&#xD;
      2 (moderate symptoms), to 3 (severe symptoms) was used to evaluate the severity of nasal&#xD;
      congestion, runny nose, itchy nose, and sneezing. Patients receiving a total score of 4 or&#xD;
      more were enrolled in the study. Patients with age below 20 years old, severe nasal septum,&#xD;
      rhinosinusitis and nasal polyposis were excluded from the study. Those who had a history of&#xD;
      immunodeficiency or previous sinus surgery, suffered from an upper respiratory tract&#xD;
      infection, or took oral corticosteroids within a month prior to the study were also excluded.&#xD;
&#xD;
      Eligible patients were randomly divided into 2 groups. Randomization assignments were&#xD;
      generated by an independent statistician. Patients in the study group were treated with one&#xD;
      treatment session of red light rhinophototherapy (RLRPT) (40mW/nostril for 15 minutes) at the&#xD;
      outpatient clinic after completing a nasal patency test using both active anterior&#xD;
      rhinomanometry and acoustic rhinometry. Upon completing RLRPT treatment, patients took a rest&#xD;
      for 30 minutes. They were then asked about the severity of their rhinitis symptoms, and as to&#xD;
      whether the overall level of change in those rhinitis symptoms was worse, unchanged, slightly&#xD;
      improved, much improved or cured. Patients were also questioned about any adverse events of&#xD;
      RLRPT before undergoing another nasal patency test. Finally, medical treatment involving an&#xD;
      intranasal steroid (mometasone furoate nasal spray, 4 sprays, once a day), along with an oral&#xD;
      antihistamine (levocetirizine 5 mg qd) was given for continued management of AR. Questions&#xD;
      regarding the severity of each patient's rhinitis symptoms, the overall change in their&#xD;
      rhinitis symptoms and any adverse events from RLRPT were asked via telephone communication 2&#xD;
      days later. Patients in the active control group were medically treated with an intranasal&#xD;
      steroid (mometasone furoate nasal spray, 4 sprays, once a day), along with an oral&#xD;
      antihistamine (levocetirizine 5 mg qd). Telephone calls were placed 2 days later in order to&#xD;
      evaluate the severity of each patient's rhinitis symptoms, along with any overall change in&#xD;
      rhinitis symptoms.&#xD;
&#xD;
      The device used for RLRPT was the Transverse Many Channels Laser Instrument (Transverse, Ind,&#xD;
      Co., Ltd., Taipei, Taiwan). It uses a red gallium-aluminum-arsenide laser with wavelengths of&#xD;
      660+10 nm as a light source. The laser has a maximum power of 40 mW. The device consists of a&#xD;
      control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient&#xD;
      put on a pair of black tinted glasses, and had the nasal probes gently placed into both&#xD;
      nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15&#xD;
      minutes during which time 36 J of light energy was delivered to each nostril.&#xD;
&#xD;
      The nasal patency was objectively measured by both active anterior rhinomanometry and&#xD;
      acoustic rhinometry. Anterior active rhinomanometry was performed according to the guidelines&#xD;
      of the International Committee on Standardization of Rhinomanometry using a NR6&#xD;
      Rhinomanometer (GM Instruments, Ltd., Kilwinning, UK). All patients remained seated for 30&#xD;
      minutes to adapt to the hospital environment prior to testing. A face mask was worn tightly.&#xD;
      The examination was performed during quiet breathing with a closed mouth, while the patient&#xD;
      was in an upright sitting position. For each nostril, inspiratory nasal resistance was&#xD;
      calculated over four inspiratory-expiratory cycles at a fixed pressure of 150 Pascal. Both&#xD;
      the total nasal airflow resistance in Pa/cm3/s, and nasal airflow in cm3/s (sum of left and&#xD;
      right) during inspiration were recorded.&#xD;
&#xD;
      An A1 Acoustic Rhinometer (GM Instruments, Ltd., Kilwinning, UK) was used to measure the&#xD;
      geometry of the nasal cavity. All patients remained seated for at least 20 minutes in order&#xD;
      to acclimatize to the hospital environment before testing. The nose piece was positioned&#xD;
      parallel to the sagittal plane of the head at a 45° angle to the coronal plane, and was&#xD;
      applied to produce an acoustic seal without distorting the outer nose. Patients were asked to&#xD;
      hold their breath and avoid swallowing during the acquisition of the acoustic data. Three&#xD;
      consecutive readings were taken to calculate an average value. An entire average acoustic&#xD;
      rhinometry curve was generated for each nasal cavity. Acoustic data included: 1) the first&#xD;
      minimal cross-sectional area (MCA1, cm2), 2) the second minimal cross sectional area (MCA2,&#xD;
      cm2), 3) the volume between the tip of the nosepiece and 3.0 cm into the nasal cavity (V03,&#xD;
      cm3), and 4) the volume of the nasal cavity between 2.0 and 5.0 cm from the tip of the&#xD;
      nosepiece (V25, cm3). We used the average value of both sides to represent the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2018</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in nasal resistance and nasal flow after red light Change from baseline in nasal resistance and nasal flow after red light rhinophototherapy</measure>
    <time_frame>before and 30 minutes after red light rhinophototherapy</time_frame>
    <description>To compare the change from baseline in nasal resistance and nasal flow 30 minutes after red light rhinophototherapy by using active anterior rhinomanometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the first and second minimal cross sectional area, and the volumes between the tip and 3.0 cm from the tip of the nosepiece and between 2.0 and 5.0 cm from the tip of the nosepiece after red light rhinophototherapy</measure>
    <time_frame>before and 30 minutes after red light rhinophototherapy</time_frame>
    <description>To compare the change from baseline in the first minimal cross sectional area of the nasal cavity, the second minimal cross sectional area of the nasal cavity, the nasal volume between the tip of the nosepiece and 3.0 cm into the nasal cavity, and the nasal volume of the nasal cavity between 2.0 and 5.0 cm from the tip of the nosepiece 30 minutes after red light rhinophototherapy by using acoustic rhinometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rhinitis symptoms</measure>
    <time_frame>before red light rhinophototherapy, and 30 minutes and 2 days after red light rhinophototherapy</time_frame>
    <description>The severity of the rhinitis symptoms was assessed through use of a standardized score scale (1). A score of 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), to 3 (severe symptoms) was used to evaluate the severity of nasal congestion, runny nose, itchy nose, and sneezing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Phototherapy</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transverse Many Channels Laser Instrument</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transverse Many Channels Laser Instrument</intervention_name>
    <description>The device consists of a control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient put on a pair of black tinted glasses, and had the nasal probes gently placed into both nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15 minutes during which time 36 J of light energy was delivered to each nostril.</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients experiencing moderate to severe symptoms of allergic rhinitis&#xD;
&#xD;
          -  Patients possessing at least one of the following symptoms: nasal congestion, runny&#xD;
             nose, itchy nose, or sneezing&#xD;
&#xD;
          -  Patients whose physical examination showing clear rhinorrhea, nasal congestion, pale&#xD;
             discoloration of the nasal mucosa, or red and watery eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with age below 20 years old&#xD;
&#xD;
          -  Patients with severe nasal septum, rhinosinusitis and nasal polyposis&#xD;
&#xD;
          -  Patients who had a history of immunodeficiency or previous sinus surgery&#xD;
&#xD;
          -  Patients who suffered from an upper respiratory tract infection&#xD;
&#xD;
          -  Patients who took oral corticosteroids within a month prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rong-San Jiang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acoustic rhinometry</keyword>
  <keyword>active anterior rhinomanometry</keyword>
  <keyword>allergic rhinitis</keyword>
  <keyword>red light rhinophototherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_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/NCT03752645
org study id: CF18014A#1
nct id: NCT03752645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the short-term effects of red light rhinophototherapy on nasal patency in
      patients with a clinical diagnosis of allergic rhinitis using both active anterior
      rhinomanometry and acoustic rhinometry.
Patients experiencing moderate to severe symptoms of allergic rhinitis (AR)were collected.
      The clinical diagnosis of AR was established when patients presented themselves with a
      history and physical examination consistent with an allergic cause. Each candidate possessed
      at least one of the following symptoms: nasal congestion, runny nose, itchy nose, or
      sneezing. All patients underwent a specific IgE test against the common perennial inhaled
      allergens found in Taiwan (house dust mites, molds, cats, dogs and cockroaches) to confirm
      the diagnosis of AR. However, these results did not exclude the patients from this study
      because only a few allergens were tested. The severity of the rhinitis symptoms was assessed
      through use of a standardized score scale (1). A score of 0 (no symptoms), 1 (mild symptoms),
      2 (moderate symptoms), to 3 (severe symptoms) was used to evaluate the severity of nasal
      congestion, runny nose, itchy nose, and sneezing. Patients receiving a total score of 4 or
      more were enrolled in the study. Patients with age below 20 years old, severe nasal septum,
      rhinosinusitis and nasal polyposis were excluded from the study. Those who had a history of
      immunodeficiency or previous sinus surgery, suffered from an upper respiratory tract
      infection, or took oral corticosteroids within a month prior to the study were also excluded.

      Eligible patients were randomly divided into 2 groups. Randomization assignments were
      generated by an independent statistician. Patients in the study group were treated with one
      treatment session of red light rhinophototherapy (RLRPT) (40mW/nostril for 15 minutes) at the
      outpatient clinic after completing a nasal patency test using both active anterior
      rhinomanometry and acoustic rhinometry. Upon completing RLRPT treatment, patients took a rest
      for 30 minutes. They were then asked about the severity of their rhinitis symptoms, and as to
      whether the overall level of change in those rhinitis symptoms was worse, unchanged, slightly
      improved, much improved or cured. Patients were also questioned about any adverse events of
      RLRPT before undergoing another nasal patency test. Finally, medical treatment involving an
      intranasal steroid (mometasone furoate nasal spray, 4 sprays, once a day), along with an oral
      antihistamine (levocetirizine 5 mg qd) was given for continued management of AR. Questions
      regarding the severity of each patient's rhinitis symptoms, the overall change in their
      rhinitis symptoms and any adverse events from RLRPT were asked via telephone communication 2
      days later. Patients in the active control group were medically treated with an intranasal
      steroid (mometasone furoate nasal spray, 4 sprays, once a day), along with an oral
      antihistamine (levocetirizine 5 mg qd). Telephone calls were placed 2 days later in order to
      evaluate the severity of each patient's rhinitis symptoms, along with any overall change in
      rhinitis symptoms.

      The device used for RLRPT was the Transverse Many Channels Laser Instrument (Transverse, Ind,
      Co., Ltd., Taipei, Taiwan). It uses a red gallium-aluminum-arsenide laser with wavelengths of
      660+10 nm as a light source. The laser has a maximum power of 40 mW. The device consists of a
      control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient
      put on a pair of black tinted glasses, and had the nasal probes gently placed into both
      nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15
      minutes during which time 36 J of light energy was delivered to each nostril.

      The nasal patency was objectively measured by both active anterior rhinomanometry and
      acoustic rhinometry. Anterior active rhinomanometry was performed according to the guidelines
      of the International Committee on Standardization of Rhinomanometry using a NR6
      Rhinomanometer (GM Instruments, Ltd., Kilwinning, UK). All patients remained seated for 30
      minutes to adapt to the hospital environment prior to testing. A face mask was worn tightly.
      The examination was performed during quiet breathing with a closed mouth, while the patient
      was in an upright sitting position. For each nostril, inspiratory nasal resistance was
      calculated over four inspiratory-expiratory cycles at a fixed pressure of 150 Pascal. Both
      the total nasal airflow resistance in Pa/cm3/s, and nasal airflow in cm3/s (sum of left and
      right) during inspiration were recorded.

      An A1 Acoustic Rhinometer (GM Instruments, Ltd., Kilwinning, UK) was used to measure the
      geometry of the nasal cavity. All patients remained seated for at least 20 minutes in order
      to acclimatize to the hospital environment before testing. The nose piece was positioned
      parallel to the sagittal plane of the head at a 45° angle to the coronal plane, and was
      applied to produce an acoustic seal without distorting the outer nose. Patients were asked to
      hold their breath and avoid swallowing during the acquisition of the acoustic data. Three
      consecutive readings were taken to calculate an average value. An entire average acoustic
      rhinometry curve was generated for each nasal cavity. Acoustic data included: 1) the first
      minimal cross-sectional area (MCA1, cm2), 2) the second minimal cross sectional area (MCA2,
      cm2), 3) the volume between the tip of the nosepiece and 3.0 cm into the nasal cavity (V03,
      cm3), and 4) the volume of the nasal cavity between 2.0 and 5.0 cm from the tip of the
      nosepiece (V25, cm3). We used the average value of both sides to represent the data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Change from baseline in nasal resistance and nasal flow after red light Change from baseline in nasal resistance and nasal flow after red light rhinophototherapy
time frame: before and 30 minutes after red light rhinophototherapy
description: To compare the change from baseline in nasal resistance and nasal flow 30 minutes after red light rhinophototherapy by using active anterior rhinomanometry
measure: Change from baseline in the first and second minimal cross sectional area, and the volumes between the tip and 3.0 cm from the tip of the nosepiece and between 2.0 and 5.0 cm from the tip of the nosepiece after red light rhinophototherapy
time frame: before and 30 minutes after red light rhinophototherapy
description: To compare the change from baseline in the first minimal cross sectional area of the nasal cavity, the second minimal cross sectional area of the nasal cavity, the nasal volume between the tip of the nosepiece and 3.0 cm into the nasal cavity, and the nasal volume of the nasal cavity between 2.0 and 5.0 cm from the tip of the nosepiece 30 minutes after red light rhinophototherapy by using acoustic rhinometry
measure: rhinitis symptoms
time frame: before red light rhinophototherapy, and 30 minutes and 2 days after red light rhinophototherapy
description: The severity of the rhinitis symptoms was assessed through use of a standardized score scale (1). A score of 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), to 3 (severe symptoms) was used to evaluate the severity of nasal congestion, runny nose, itchy nose, and sneezing.
arm group label: intervention
arm group type: Experimental
description: Transverse Many Channels Laser Instrument
arm group label: control
arm group type: No Intervention
intervention type: Device
intervention name: Transverse Many Channels Laser Instrument
description: The device consists of a control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient put on a pair of black tinted glasses, and had the nasal probes gently placed into both nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15 minutes during which time 36 J of light energy was delivered to each nostril.
arm group label: intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Rong-San Jiang, MD, PhD
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic