<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/NCT03039816</url>
  </required_header>
  <id_info>
    <org_study_id>NIL001/2013</org_study_id>
    <nct_id>NCT03039816</nct_id>
  </id_info>
  <brief_title>Cellulose Powder Against Grass Pollen Allergic Rhinitis</brief_title>
  <acronym>CPARGPDBPC</acronym>
  <official_title>A Nasally Applied Cellulose Powder in Seasonal Allergic Rhinitis in Adults With Grass Pollen Allergy: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nasaleze International Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nasaleze International Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: A nasally applied cellulose powder is increasingly used in many countries as a&#xD;
      remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children&#xD;
      showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen&#xD;
      counts. The present study in grass pollen-allergic adults used the same basic design.&#xD;
      Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients&#xD;
      with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were&#xD;
      used as reminders of treatment and reporting of symptom scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May&#xD;
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a&#xD;
      history of typical symptoms of seasonal allergic rhinitis (SAR) during late spring - early&#xD;
      summer. At first appointment the history was scrutinized and an assessment of the severity&#xD;
      excluded previous use of nasal steroids or a current need for nasal steroids. They should not&#xD;
      have perennial symptoms or a history of asthma. They were tested with a blood sample for&#xD;
      ImmunoCAP Specific Immunoglobulin E (IgE) for timothy grass pollen and birch pollen, with&#xD;
      &gt;0.35 Kilounits (kU)/ml counted as positive.&#xD;
&#xD;
      The patients were randomly assigned to active or placebo in groups using an identical device&#xD;
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic&#xD;
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered&#xD;
      is not standardized and the variations of patterns of deposition in the nose are not known.&#xD;
      The placebo was a lactose powder with the same particle size, appearance and the same tinge&#xD;
      of mint taste as the cellulose powder.&#xD;
&#xD;
      Rescue medication could be obtained by the investigators after emergency contacts. Oral&#xD;
      antihistamine was loratadine 10 mg tablets and sodium chromoglycate eye drops. Each subject&#xD;
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started&#xD;
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment&#xD;
      during the grass pollen season&#xD;
&#xD;
      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked&#xD;
      to confirm the intake by a response SMS. In the evening, they were asked about the severity&#xD;
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with&#xD;
      a figure 1-6, corresponding to 1 &quot;no trouble at all&quot;, 2&quot;little trouble&quot;, 3&quot;moderate trouble&quot;,&#xD;
      4&quot;rather much trouble&quot;, 5&quot;much trouble&quot;, and 6 &quot;very much trouble&quot; respectively. From the&#xD;
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and&#xD;
      lower airways, respectively, only a concluding figure was used.&#xD;
&#xD;
      In the registration a question was added daily on the use of rescue medication.&#xD;
&#xD;
      At a concluding appointment after the treatment period, the subjects were asked about their&#xD;
      global opinion of the efficacy: No effect, good effect, very good effect. They also were&#xD;
      asked whether they believed they had obtained the active substance or placebo.&#xD;
&#xD;
      The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May&#xD;
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a&#xD;
      history of typical symptoms of SAR during late spring - early summer. At first appointment&#xD;
      the history was scrutinized and an assessment of the severity excluded previous use of nasal&#xD;
      steroids or a current need for nasal steroids. They should not have perennial symptoms or a&#xD;
      history of asthma. They were tested with a blood sample for ImmunoCAP Specific IgE for&#xD;
      timothy grass pollen and birch pollen, with &gt;0.35 kU/ml counted as positive.&#xD;
&#xD;
      The patients were randomly assigned to active or placebo in groups using an identical device&#xD;
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic&#xD;
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered&#xD;
      is not standardized and the variations of patterns of deposition in the nose are not known.&#xD;
      The placebo was a lactose powder with the same particle size, appearance and the same tinge&#xD;
      of mint taste as the cellulose powder.&#xD;
&#xD;
      Rescue medication could be obtained by the investigators after emergency contacts. Oral&#xD;
      antihistamine was loratadine 10 mg tablets and sodium cromoglycate eye drops. Each subject&#xD;
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started&#xD;
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment&#xD;
      during the grass pollen season&#xD;
&#xD;
      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked&#xD;
      to confirm the intake by a response SMS. In the evening, they were asked about the severity&#xD;
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with&#xD;
      a figure 1-6, corresponding to 1 &quot;no trouble at all&quot;, 2&quot;little trouble&quot;, 3&quot;moderate trouble&quot;,&#xD;
      4&quot;rather much trouble&quot;, 5&quot;much trouble&quot;, and 6 &quot;very much trouble&quot; respectively. From the&#xD;
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and&#xD;
      lower airways, respectively, only a concluding figure was used.&#xD;
&#xD;
      In the registration a question was added daily on the use of rescue medication.&#xD;
&#xD;
      At a concluding appointment after the treatment period, the subjects were asked about their&#xD;
      global opinion of the efficacy: No effect, good effect, very good effect. They also were&#xD;
      asked whether they believed they had obtained the active substance or placebo.&#xD;
&#xD;
      Statistical methods For each question the mean score was calculated for the whole 28 days&#xD;
      period for every subject. Mean values for the sum of all scores as well as the sum of the&#xD;
      nasal scores were also calculated. The scores from the two treatment groups were then&#xD;
      compared using t-tests. The group comparison of reflective opinions and the guess on obtained&#xD;
      medication at the follow up visit were assessed using the Chi-square test.&#xD;
&#xD;
      The concluding opinion at the follow up visit were analysed using the chi-square test.&#xD;
&#xD;
      The study was approved by the local ethics committees at the respective hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms of allergic rhinitis</measure>
    <time_frame>Day 1-28 of treatment period</time_frame>
    <description>Group total of symptoms scored retrospectively once daily</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Day 1-28 and day 32</time_frame>
    <description>Answer on daily question on Short Message Service (SMS) during treatment and supplementing interview at concluding appointment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>Treatment period day 1-28</time_frame>
    <description>Daily answer on SMS question on possible use of rescue medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global opinion of the efficacy</measure>
    <time_frame>Day 32, after completed treatment</time_frame>
    <description>Questions on alternatives &quot;No effect, good effect, very good effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Guess on obtained treatment</measure>
    <time_frame>Day 32, after completed treatment</time_frame>
    <description>Question on whether they believed they had obtained the active substance or placebo.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients were randomly assigned to active (Nasaleze cellulose powder) or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patients were randomly assigned to active or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasaleze</intervention_name>
    <description>Nasaleze cellulose powder</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Nasaval</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lactose powder in the same plastic container as Nasaleze and with the same taste</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a history of typical symptoms of hay fever during late spring or early&#xD;
             summer&#xD;
&#xD;
          -  Mild or moderate severity of symptoms of seasonal allergic rhinitis.&#xD;
&#xD;
          -  Positive allergy test for grass pollen allergy.&#xD;
&#xD;
          -  Voluntarily given written informed consent to study participation encompassing consent&#xD;
             to data recording and verification procedures;&#xD;
&#xD;
          -  Patients are able and willing to comply with the requirements of the study protocol.&#xD;
&#xD;
          -  Patients who have not received any pollen disease treatment for one week prior to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with nasal steroids or current indications for the administration&#xD;
             of nasal steroids.&#xD;
&#xD;
          -  Nasal symptoms during all seasons of the year or during spring time preceding the&#xD;
             grass pollen season.&#xD;
&#xD;
          -  Clinical signs of predominating nasal obstruction. The patient must be judged to be&#xD;
             able to reach the nasal cavity with the study powder.&#xD;
&#xD;
          -  Other respiratory or chronic diseases.&#xD;
&#xD;
          -  Previous use of the study product&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Departments of Pediatrics and Biological and Environmental Sciences</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mechanikov Dnipropetrovsk Regional Clinical Hospital, Departmnet of Profpathology, Zhovteneva sq 14</name>
      <address>
        <city>Dnipropetrovs'k</city>
        <zip>49106</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv National Medical University Department of Internal medicine propedeutics No 2 4 Lenin str</name>
      <address>
        <city>Kharkiv</city>
        <zip>61022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
    <country>Ukraine</country>
  </location_countries>
  <results_reference>
    <citation>Aberg N, Ospanova ST, Nikitin NP, Emberlin J, Dahl A. A nasally applied cellulose powder in seasonal allergic rhinitis in adults with grass pollen allergy: a double-blind, randomized, placebo-controlled, parallel-group study. Int Arch Allergy Immunol. 2014;163(4):313-8. doi: 10.1159/000360734. Epub 2014 Apr 29.</citation>
    <PMID>24852424</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03039816
org study id: NIL001/2013
nct id: NCT03039816
lead sponsor: 
collaborator: 
has dmc: No
Background: A nasally applied cellulose powder is increasingly used in many countries as a
      remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children
      showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen
      counts. The present study in grass pollen-allergic adults used the same basic design.
      Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients
      with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were
      used as reminders of treatment and reporting of symptom scores.
The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a
      history of typical symptoms of seasonal allergic rhinitis (SAR) during late spring - early
      summer. At first appointment the history was scrutinized and an assessment of the severity
      excluded previous use of nasal steroids or a current need for nasal steroids. They should not
      have perennial symptoms or a history of asthma. They were tested with a blood sample for
      ImmunoCAP Specific Immunoglobulin E (IgE) for timothy grass pollen and birch pollen, with
      >0.35 Kilounits (kU)/ml counted as positive.

      The patients were randomly assigned to active or placebo in groups using an identical device
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered
      is not standardized and the variations of patterns of deposition in the nose are not known.
      The placebo was a lactose powder with the same particle size, appearance and the same tinge
      of mint taste as the cellulose powder.

      Rescue medication could be obtained by the investigators after emergency contacts. Oral
      antihistamine was loratadine 10 mg tablets and sodium chromoglycate eye drops. Each subject
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment
      during the grass pollen season

      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked
      to confirm the intake by a response SMS. In the evening, they were asked about the severity
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with
      a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble",
      4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and
      lower airways, respectively, only a concluding figure was used.

      In the registration a question was added daily on the use of rescue medication.

      At a concluding appointment after the treatment period, the subjects were asked about their
      global opinion of the efficacy: No effect, good effect, very good effect. They also were
      asked whether they believed they had obtained the active substance or placebo.

      The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a
      history of typical symptoms of SAR during late spring - early summer. At first appointment
      the history was scrutinized and an assessment of the severity excluded previous use of nasal
      steroids or a current need for nasal steroids. They should not have perennial symptoms or a
      history of asthma. They were tested with a blood sample for ImmunoCAP Specific IgE for
      timothy grass pollen and birch pollen, with >0.35 kU/ml counted as positive.

      The patients were randomly assigned to active or placebo in groups using an identical device
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered
      is not standardized and the variations of patterns of deposition in the nose are not known.
      The placebo was a lactose powder with the same particle size, appearance and the same tinge
      of mint taste as the cellulose powder.

      Rescue medication could be obtained by the investigators after emergency contacts. Oral
      antihistamine was loratadine 10 mg tablets and sodium cromoglycate eye drops. Each subject
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment
      during the grass pollen season

      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked
      to confirm the intake by a response SMS. In the evening, they were asked about the severity
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with
      a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble",
      4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and
      lower airways, respectively, only a concluding figure was used.

      In the registration a question was added daily on the use of rescue medication.

      At a concluding appointment after the treatment period, the subjects were asked about their
      global opinion of the efficacy: No effect, good effect, very good effect. They also were
      asked whether they believed they had obtained the active substance or placebo.

      Statistical methods For each question the mean score was calculated for the whole 28 days
      period for every subject. Mean values for the sum of all scores as well as the sum of the
      nasal scores were also calculated. The scores from the two treatment groups were then
      compared using t-tests. The group comparison of reflective opinions and the guess on obtained
      medication at the follow up visit were assessed using the Chi-square test.

      The concluding opinion at the follow up visit were analysed using the chi-square test.

      The study was approved by the local ethics committees at the respective hospitals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Symptoms of allergic rhinitis
time frame: Day 1-28 of treatment period
description: Group total of symptoms scored retrospectively once daily
measure: Adverse events
time frame: Day 1-28 and day 32
description: Answer on daily question on Short Message Service (SMS) during treatment and supplementing interview at concluding appointment
measure: Use of rescue medication
time frame: Treatment period day 1-28
description: Daily answer on SMS question on possible use of rescue medication
measure: Global opinion of the efficacy
time frame: Day 32, after completed treatment
description: Questions on alternatives "No effect, good effect, very good effect
measure: Guess on obtained treatment
time frame: Day 32, after completed treatment
description: Question on whether they believed they had obtained the active substance or placebo.
arm group label: Active
arm group type: Active Comparator
description: The patients were randomly assigned to active (Nasaleze cellulose powder) or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
arm group label: Placebo
arm group type: Placebo Comparator
description: The patients were randomly assigned to active or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
intervention type: Device
intervention name: Nasaleze
description: Nasaleze cellulose powder
arm group label: Active
other name: Nasaval
intervention type: Device
intervention name: Placebo
description: Lactose powder in the same plastic container as Nasaleze and with the same taste
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Sweden
country: Ukraine
citation: Aberg N, Ospanova ST, Nikitin NP, Emberlin J, Dahl A. A nasally applied cellulose powder in seasonal allergic rhinitis in adults with grass pollen allergy: a double-blind, randomized, placebo-controlled, parallel-group study. Int Arch Allergy Immunol. 2014;163(4):313-8. doi: 10.1159/000360734. Epub 2014 Apr 29.
PMID: 24852424
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
sharing ipd: No