Corn Occupational Rhinitis SCIT Efficacy Study

NCT02949050 | Unknown DMC

• 1 other identifier: Corn SCIT study-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Corn based Occupational Rhinitis quality of life surveys

  Actual survey completions take less than 1 day.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

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

Interventions

subcutaneous allergen immunotherapy (SCIT) BIOLOGICAL

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.

Treatment Group

SCIT BIOLOGICAL

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

Treatment Group

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completing more than 1 year of timothy grass SCIT
• Residing/working on/near a corn farm
• Having an initial symptom score value of \> 8 (out of a possible 21).
• Never treated with SCIT.
• Residing/working on/near a corn farm
• Having an initial symptom score value of \> 8 (out of a possible 21).
• All accepted enrolled patients are healthy volunteers.

You may not qualify if:

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

Sponsors & Collaborators

• United Allergy Services: lead

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• frederick m schaffer, md

  United Allergy Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: October 31, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share