Corn Occupational Rhinitis SCIT Efficacy Study

Not Applicable

• Conditions: Rhinitis
• Interventions: Biological: subcutaneous allergen immunotherapy (SCIT); Biological: SCIT

• Registration Number: NCT02949050
• Lead Sponsor: United Allergy Services

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 Description

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-31
• Primary Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1. Negative allergy test to corn pollen,
2. Not residing on/near farm growing corn,
3. An initial symptom score of < 9.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	SCIT	the treatment -patients underwent SCIT and antihistamine/nasal steroid/use.
Treatment Group	subcutaneous allergen immunotherapy (SCIT)	the treatment -patients underwent SCIT and antihistamine/nasal steroid/use.

Primary Outcome Measures

Name	Time	Method
Corn based Occupational Rhinitis symptom and medication score surveys	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.

Secondary Outcome Measures

Name	Time	Method
Corn based Occupational Rhinitis quality of life surveys	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.