The Efficacy & Safety of the UAS Immunotherapy Protocol

NCT01699659 | Completed DMC

• 1 other identifier: UAS protocol #1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perennial Allergic Rhinitis With Seasonal Variation

Keywords

Allergic Rhinitis; Allergen Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Quality of Life (QOL) scores

  Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy

Interventions

allergen immunotherapy OTHER

allergy shots

Also known as: allergy shots

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Allergy Services: lead

Study Sites (1)

UAS

San Antonio, Texas, 78216, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Frederick M Schaffer, M.D.

  United Allergy Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: October 4, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

US (1)