Perennial Allergic Rhinitis With Seasonal Variation Clinical Trial
Official title:
The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol
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 |
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.
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. |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | UAS | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
United Allergy Services |
United States,
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 |