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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014