Corn Occupational Rhinitis SCIT Efficacy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

NCT01353079

Allergy

COMPLETED PHASE3

Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies

NCT00599872

Allergic Rhinitis

COMPLETED PHASE3

Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

NCT00955825

Allergic Rhinitis Due to Grass Pollens

COMPLETED PHASE3

The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions

NCT01878929

Allergic Rhinitis Asthma Allergic Conjunctivitis

UNKNOWN PHASE1/PHASE2

Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis

NCT00550875

Allergic Rhinoconjunctivitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

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

Group Type EXPERIMENTAL

subcutaneous allergen immunotherapy (SCIT)

Intervention Type 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.

SCIT

Intervention Type BIOLOGICAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

SCIT

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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).

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.