Corn Occupational Rhinitis SCIT Efficacy Study

Rhinitis Clinical Trial

Official title:

Corn Based Occupational Rhinitis; SCIT Efficacy Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02949050
• Other study ID #: Corn SCIT study-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: United Allergy Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis

Intervention

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.
• SCIT
Treatment group consists of patients who completed > 1 year of SCIT while control group patients did not undergo SCIT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United Allergy Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.