Clinical Trial: Corn Occupational Rhinitis SCIT Efficacy Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Corn Based Occupational Rhinitis; SCIT Efficacy Study

Brief Summary: Patients demonstrated allergic to corn pollen and timothy grass pollen (by allergy testing) who have undergone 1 to 2 years of subcutaneous allergen immunotherapy (SCIT) containing timothy grass extract with moderate symptomology (as documented via rhinitis symptom score surveys) will constitute the treatment group. Those who previously chose not to undergo SCIT who have documented symptomology and are skin test positive to corn pollen will constitute the control group. Prospective symptom score analyses and retrospective quality of life assessments (RQLQ) will be the primary and secondary efficacy outcome measures.

Detailed Summary: Statistical assessment suggests enrollment of 20 patients into the treatment group (defined above) and an additional 20 into the control group. Patients will be matched for the level of symptomology (based on symptom score surveys) and residing/working on corn-crop farms. The premise for this study is the cross-reactivity of putative immunogenic sites between timothy grass pollen and corn pollen. based on consensus genetic sequences. Thus, the hypothesis is the use of Timothy grass extract containing immunotherapy would diminish symptomology to corn-based occupational rhinitis. Enrolled patients will have signed IRB approved consent forms and have undergone SCIT for 1 to 2 plus years (treatment group) or not undergone SCIT therapy for the same time period (control group). Potential contribution to symptom scores from other sources (e.g. Ragweed) will be analyzed by assessment of local pollen counts.Efficacy assessment will compare prospective symptom score results and retrospective quality of life survey scores between the treatment and control group responses.
Sponsor: United Allergy Services

Current Primary Outcome: Corn based Occupational Rhinitis symptom and medication score surveys [ Time Frame: prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys. ]

The completed symptom and medication score surveys will be contrasted from before to after therapy and between treatment and control groups.


Original Primary Outcome: Same as current

Current Secondary Outcome: Corn based Occupational Rhinitis quality of life surveys [ Time Frame: Actual survey completions take less than 1 day. ]

secondary outcome measure-completed quality of life surveys will be assessed from before to after therapy and between the treatment and control groups.


Original Secondary Outcome: Same as current

Information By: United Allergy Services

Dates:
Date Received: August 29, 2016
Date Started: August 2016
Date Completion: January 2017
Last Updated: October 26, 2016
Last Verified: October 2016