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The Efficacy & Safety of the UAS Immunotherapy Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederick M. Schaffer, MD, United Allergy Services
ClinicalTrials.gov Identifier:
NCT01699659
First received: September 10, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.


Condition Intervention
Perennial Allergic Rhinitis With Seasonal Variation
 Other: allergen immunotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by United Allergy Services:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: allergen immunotherapy
    allergy shots
    Other Name: allergy shots
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).

Criteria

Inclusion Criteria:

  • Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.

Exclusion Criteria:

  • No beta blocker use,
  • no pregnancy,
  • no systemic steroids,
  • no severe asthma/copd,
  • no severe collagen vascular disorders,
  • no neoplastic or uncontrolled seizure activity,
  • no previous anaphylaxis, no significant cardiovsacular disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699659

Locations
United States, Texas
UAS
San Antonio, Texas, United States, 78216
Sponsors and Collaborators
United Allergy Services
Investigators
Principal Investigator: Frederick M Schaffer, M.D. United Allergy Services
  More Information

No publications provided

Responsible Party: Frederick M. Schaffer, MD, Chief Medical Officer, United Allergy Services
ClinicalTrials.gov Identifier: NCT01699659     History of Changes
Other Study ID Numbers: UAS protocol #1, UAS protocol #1
Study First Received: September 10, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by United Allergy Services:
Allergic Rhinitis
Allergen Immunotherapy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013