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Completed

NCT Number: NCT01699659

The Efficacy & Safety of the UAS Immunotherapy Protocol

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

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Key information

Conditions

Perennial Allergic Rhinitis With Seasonal Variation Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UAS

San Antonio, Texas, 78216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

allergen immunotherapy

Other

allergy shots

Other names: allergy shots

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).

    Time frame: 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 outcomes

  1. 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.

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

United Allergy Services

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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