The Efficacy & Safety of the UAS Immunotherapy Protocol

Perennial Allergic Rhinitis With Seasonal Variation Clinical Trial

Official title:

The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699659
• Other study ID #: UAS protocol #1
• Secondary ID: UAS protocol #1
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: October 3, 2012
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: United Allergy Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis With Seasonal Variation
• Rhinitis, Allergic, Perennial

Intervention

Other:
• allergen immunotherapy
allergy shots

Locations

Country	Name	City	State
United States	UAS	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United Allergy Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life (QOL) scores	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.	Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy	No
Primary	change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).	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.	Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.	No
Secondary	Changes in medication plus symptom aggregate score.	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.	Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.	No