Corn Occupational Rhinitis SCIT Efficacy Study

United Allergy Services

Status: Unknown

Conditions: Rhinitis

Treatments: Biological: subcutaneous allergen immunotherapy (SCIT); Biological: SCIT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949050

Corn SCIT study-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment Group

Experimental group

Description:

the treatment -patients underwent SCIT and antihistamine/nasal steroid/use.

Treatment:

Biological: SCIT

Biological: subcutaneous allergen immunotherapy (SCIT)

Control Group

No Intervention group

Description:

Control patient group only used antihistamines/nasal steroids but no SCIT