Clinical trial NCT02949050: Corn Occupational Rhinitis SCIT Efficacy Study
Official title: Corn Based Occupational Rhinitis; SCIT Efficacy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhinitis
Lead sponsor: United Allergy Services
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Corn based Occupational Rhinitis symptom and medication score surveys
timeFrame: prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys.
Secondary outcomes:
measure: Corn based Occupational Rhinitis quality of life surveys
timeFrame: Actual survey completions take less than 1 day.
Other outcomes:
Locations:
Study officials:
affiliation: United Allergy Services
name: frederick m schaffer, md
role: PRINCIPAL_INVESTIGATOR
References: