<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/NCT01699659</url>
  </required_header>
  <id_info>
    <org_study_id>UAS protocol #1</org_study_id>
    <secondary_id>UAS protocol #1</secondary_id>
    <nct_id>NCT01699659</nct_id>
  </id_info>
  <brief_title>The Efficacy &amp; Safety of the UAS Immunotherapy Protocol</brief_title>
  <official_title>The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Allergy Services</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Allergy Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as&#xD;
      protocols described in the Allergy literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be assessed for efficacy of the immunotherapy protocol by completing&#xD;
      Consented-IRB approved clinical, medication, quality of life survey questions comparing&#xD;
      current status while on therapy in contrast to 12 months before the inception of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).</measure>
    <time_frame>Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.</time_frame>
    <description>Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in medication plus symptom aggregate score.</measure>
    <time_frame>Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.</time_frame>
    <description>Aggregate Medication and Symptom surveys were compared to determine changes from a 12 month time point prior to inception of therapy to current time point of 1 to 2 years of therapy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life (QOL) scores</measure>
    <time_frame>Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy</time_frame>
    <description>QOL scores will be calculated after one to 2 years of therapy and contrasted with QOL reflecting status 12 months prior to initiation of therapy.</description>
  </other_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Perennial Allergic Rhinitis With Seasonal Variation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>allergen immunotherapy</intervention_name>
    <description>allergy shots</description>
    <other_name>allergy shots</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Allergic rhinitis between 18 and 65 years old who have chosen to undergo&#xD;
             immunotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No beta blocker use,&#xD;
&#xD;
          -  no pregnancy,&#xD;
&#xD;
          -  no systemic steroids,&#xD;
&#xD;
          -  no severe asthma/copd,&#xD;
&#xD;
          -  no severe collagen vascular disorders,&#xD;
&#xD;
          -  no neoplastic or uncontrolled seizure activity,&#xD;
&#xD;
          -  no previous anaphylaxis, no significant cardiovsacular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick M Schaffer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>United Allergy Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAS</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United Allergy Services</investigator_affiliation>
    <investigator_full_name>Frederick M. Schaffer, MD</investigator_full_name>
    <investigator_title>Chief Medical Officer</investigator_title>
  </responsible_party>
  <keyword>Allergic Rhinitis</keyword>
  <keyword>Allergen Immunotherapy</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>
    <mesh_term>Rhinitis, Allergic, Perennial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</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/NCT01699659
org study id: UAS protocol #1
secondary id: UAS protocol #1
nct id: NCT01699659
lead sponsor: 
has dmc: Yes
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as
      protocols described in the Allergy literature.
Patients will be assessed for efficacy of the immunotherapy protocol by completing
      Consented-IRB approved clinical, medication, quality of life survey questions comparing
      current status while on therapy in contrast to 12 months before the inception of therapy.
observational model: Case-Only
time perspective: Retrospective
measure: change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).
time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
description: Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy.
measure: Changes in medication plus symptom aggregate score.
time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.
description: Aggregate Medication and Symptom surveys were compared to determine changes from a 12 month time point prior to inception of therapy to current time point of 1 to 2 years of therapy.
measure: Quality of Life (QOL) scores
time frame: Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy
description: QOL scores will be calculated after one to 2 years of therapy and contrasted with QOL reflecting status 12 months prior to initiation of therapy.
intervention type: Other
intervention name: allergen immunotherapy
description: allergy shots
other name: allergy shots
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick M Schaffer, M.D.
role: Principal Investigator
affiliation: United Allergy Services
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: United Allergy Services
investigator full name: Frederick M. Schaffer, MD
investigator title: Chief Medical Officer
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
mesh term: Immunomodulating Agents