<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/NCT02238210</url>
  </required_header>
  <id_info>
    <org_study_id>244.2503</org_study_id>
    <nct_id>NCT02238210</nct_id>
  </id_info>
  <brief_title>Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy</brief_title>
  <official_title>A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) With Rhinorrhea Associated With a Common Cold or Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5&#xD;
      years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from&#xD;
      symptoms of rhinorrhea associated with allergies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2002</start_date>
  <primary_completion_date type="Actual">May 2003</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient's parent/legal guardian global assessment - common cold group</measure>
    <time_frame>Day 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 21 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's parent/legal guardian global assessment - allergy group</measure>
    <time_frame>Day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group</measure>
    <time_frame>Day 4</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group</measure>
    <time_frame>Day 4</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group</measure>
    <time_frame>Day 4</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically findings in nasal and otoscopic examination - common cold group</measure>
    <time_frame>up to day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group</measure>
    <time_frame>Day 14</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group</measure>
    <time_frame>Day 14</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group</measure>
    <time_frame>Day 14</time_frame>
    <description>daily assessment by e-diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically findings in nasal and otoscopic examination - allergy group</measure>
    <time_frame>up to day 14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Cold</condition>
  <arm_group>
    <arm_group_label>Atrovent® - common cold group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment duration for common cold group - three time daily for 4 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Atrovent® - allergy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment duration for allergy group - three time daily for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atrovent®</intervention_name>
    <arm_group_label>Atrovent® - common cold group</arm_group_label>
    <arm_group_label>Experimental: Atrovent® - allergy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients with common cold&#xD;
&#xD;
          -  Male or female at least 2 but not older than 5 years of age at screening&#xD;
&#xD;
          -  Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea&#xD;
             (within 48 hours of screening visit) and at least 1 of the following:&#xD;
&#xD;
               -  Presence of swollen nasal membranes characteristic of a common cold on&#xD;
                  examination at screening&#xD;
&#xD;
               -  Presence of fever up to 102°F (oral or equivalent) within 48 hours of visit (may&#xD;
                  be taken at home/away from the clinic) or at time of screening&#xD;
&#xD;
          -  Capability of parent/legal guardian to read and understand the informed consent,&#xD;
             record trial diary information, administer trial drug and read and understand trial&#xD;
             assessment questionnaire&#xD;
&#xD;
        Inclusion Criteria for patients with allergies&#xD;
&#xD;
          -  Male or female at least 2 but not older than 5 year of age&#xD;
&#xD;
          -  Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of&#xD;
             the following:&#xD;
&#xD;
               -  Positive skin or Radioallergosorbent test (RAST) test to a relevant allergen&#xD;
                  within 12 months of screening or at the screening visit. For the purpose of this&#xD;
                  trial a positive skin test is defined as wheal diameter that is at least 3 mm&#xD;
                  greater than the negative control&#xD;
&#xD;
               -  Positive prior history for atopy with nasal symptoms associated with expose to&#xD;
                  allergens&#xD;
&#xD;
          -  Symptoms associated with rhinorrhea for at least 48 hours prior to the screening visit&#xD;
&#xD;
          -  Capability of parent/legal guardian to read and understand the informed consent,&#xD;
             record trial diary information, administer trial drug and read and understand trial&#xD;
             assessment questionnaire&#xD;
&#xD;
        General Exclusion Criteria for both common cold and allergy&#xD;
&#xD;
          -  Significant cardiovascular, renal, hepatic, endocrine, metabolic, neurologic or other&#xD;
             systemic disease. A significant disease was defined as one which, in the opinion of&#xD;
             the Investigator, either put the patient at risk because of participation in the trial&#xD;
             or influenced the results of the trial or the patient's ability to participate in the&#xD;
             trial&#xD;
&#xD;
          -  Presence of rales or rhonchi suggestive of a lower respiratory tract infection&#xD;
&#xD;
          -  An oral (or equivalent) temperature higher than 102°F&#xD;
&#xD;
          -  Presence of otitis media&#xD;
&#xD;
          -  Be initiating or advancing immunotherapy regimen during the course of this trial.&#xD;
             Patients receiving a maintenance dose of immunotherapy are eligible&#xD;
&#xD;
          -  Known intolerance to anticholinergics of hypersensitivity to benzalkonium chloride&#xD;
&#xD;
          -  Excluded medications prior to Visit 1 and during the trial included:&#xD;
&#xD;
               1. 24 hours before&#xD;
&#xD;
                    -  Over-the-counter decongestants or nasal/ocular cromolyn&#xD;
&#xD;
               2. 3 days before:&#xD;
&#xD;
                    -  Anticholinergics&#xD;
&#xD;
                    -  Over-the-counter antihistamines&#xD;
&#xD;
                    -  sympathomimetic decongestants&#xD;
&#xD;
               3. 5 days before:&#xD;
&#xD;
                    -  Fexofenadine&#xD;
&#xD;
                    -  Loratadine&#xD;
&#xD;
               4. 7 days before:&#xD;
&#xD;
                    -  Cetirizine&#xD;
&#xD;
                    -  antihistamines such as Atarax® or doxepin hydrochloride&#xD;
&#xD;
                    -  Antidepressants&#xD;
&#xD;
               5. 14 days before:&#xD;
&#xD;
                    -  Intranasal steroids&#xD;
&#xD;
               6. 28 days before:&#xD;
&#xD;
                    -  Steroids (oral and injectable)&#xD;
&#xD;
                    -  Leukotriene modifiers (e.g. Accolate®, Singulair®)&#xD;
&#xD;
                    -  Other investigational drugs&#xD;
&#xD;
          -  Participation in any trial with an investigational drug within 30 days of the&#xD;
             screening visit&#xD;
&#xD;
          -  Nasal obstruction greater than 50% that would prevent deposition of trial drug&#xD;
&#xD;
          -  The parent/legal guardian has a disability or lives in a geographical location that&#xD;
             could impair compliance with the protocol or visits to the trial center&#xD;
&#xD;
        Exclusion criteria for patients with a common cold&#xD;
&#xD;
          -  History or perennial allergic rhinitis or seasonal allergic rhinitis (SAR) with&#xD;
             allergen in season&#xD;
&#xD;
          -  Positive Streptococcus test&#xD;
&#xD;
        Exclusion criteria for patients with allergies&#xD;
&#xD;
          -  Patients with active infectious rhinitis (common cold) as determined by history and&#xD;
             physical&#xD;
&#xD;
          -  Patients with upper or lower respiratory infection at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</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>Common Cold</mesh_term>
    <mesh_term>Rhinorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipratropium</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/NCT02238210
org study id: 244.2503
nct id: NCT02238210
lead sponsor: 
Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5
      years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from
      symptoms of rhinorrhea associated with allergies
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient's parent/legal guardian global assessment - common cold group
time frame: Day 4
measure: Number of patients with adverse events
time frame: up to 21 days
measure: Patient's parent/legal guardian global assessment - allergy group
time frame: Day 14
measure: Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group
time frame: Day 4
description: daily assessment by e-diary
measure: Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group
time frame: Day 4
description: daily assessment by e-diary
measure: Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group
time frame: Day 4
description: daily assessment by e-diary
measure: Number of patients with clinically findings in nasal and otoscopic examination - common cold group
time frame: up to day 4
measure: Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group
time frame: Day 14
description: daily assessment by e-diary
measure: Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group
time frame: Day 14
description: daily assessment by e-diary
measure: Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group
time frame: Day 14
description: daily assessment by e-diary
measure: Number of patients with clinically findings in nasal and otoscopic examination - allergy group
time frame: up to day 14
arm group label: Atrovent® - common cold group
arm group type: Experimental
description: Treatment duration for common cold group - three time daily for 4 days
arm group label: Experimental: Atrovent® - allergy group
arm group type: Experimental
description: Treatment duration for allergy group - three time daily for 14 days
intervention type: Drug
intervention name: Atrovent®
arm group label: Atrovent® - common cold group
arm group label: Experimental: Atrovent® - allergy group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Rhinorrhea
mesh term: Ipratropium