Corn Occupational Rhinitis SCIT Efficacy Study

Corn Based Occupational Rhinitis; SCIT Efficacy Study

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.

Study Overview

• Status: Unknown
• Conditions: Rhinitis
• Intervention / Treatment: Biological: subcutaneous allergen immunotherapy (SCIT); Biological: SCIT

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for treatment group:

1. Completing more than 1 year of timothy grass SCIT
2. Residing/working on/near a corn farm
3. Having an initial symptom score value of > 8 (out of a possible 21).

Inclusion Criteria for control group:

1. Never treated with SCIT.
2. Residing/working on/near a corn farm
3. Having an initial symptom score value of > 8 (out of a possible 21).

All accepted enrolled patients are healthy volunteers.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; the treatment -patients underwent SCIT and antihistamine/nasal steroid/use.	Biological: subcutaneous allergen immunotherapy (SCIT); 20 patients who (prior to study enrollment and initiation) completed more than 1 year of timothy grass SCIT vs. 20 control patients who underwent corn pollen exposure for for greater than one year during the same prestudy time interval. Efficacy will be assessed by analyses of symptom score surveys and quality of life surveys.; Biological: SCIT; Treatment group consists of patients who completed > 1 year of SCIT while control group patients did not undergo SCIT
No Intervention: Control Group; Control patient group only used antihistamines/nasal steroids but no SCIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corn based Occupational Rhinitis symptom and medication score surveys	The completed symptom and medication score surveys will be contrasted from before to after therapy and between treatment and control groups.	prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corn based Occupational Rhinitis quality of life surveys	secondary outcome measure-completed quality of life surveys will be assessed from before to after therapy and between the treatment and control groups.	Actual survey completions take less than 1 day.

Collaborators and Investigators

• Sponsor: United Allergy Services
• Investigators: Principal Investigator: frederick m schaffer, md, United Allergy Services

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: Corn SCIT study-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO