The Efficacy & Safety of the UAS Immunotherapy Protocol

Completed

• Conditions: Perennial Allergic Rhinitis With Seasonal Variation

• Registration Number: NCT01699659
• Lead Sponsor: United Allergy Services

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-09-10
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).	Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.	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

Name	Time	Method
Changes in medication plus symptom aggregate score.	Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.	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.

Trial Locations

Locations (1)

UAS; 🇺🇸 San Antonio, Texas, United States