Corn Occupational Rhinitis SCIT Efficacy Study

Status Enrolling by invitation

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Rhinitis

Clinical Trial Details

NCT number	NCT02949050
Study type	Interventional
Source	United Allergy Services
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	August 2016
Completion date	December 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02340130` - Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma	Phase 2
Completed	`NCT02360072` - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed	`NCT01118312` - Study of Asthma and Nasal Steroids	Phase 4
Completed	`NCT00762567` - Phenylephrine Pediatric Pharmacokinetic Study	Phase 1
Completed	`NCT00541255` - A Long-Term Examination of Asthma From Childhood Through Adolescence
Completed	`NCT00279916` - Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays	Phase 3
Completed	`NCT00963573` - Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)	Phase 4
Completed	`NCT00524836` - Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis	Phase 3
Completed	`NCT00521131` - Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites	Phase 4
Completed	`NCT04132570` - A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution	Phase 4
Completed	`NCT02784262` - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis	Phase 2
Terminated	`NCT02630472` - Topical Irrigation Therapy for CRS	Phase 1/Phase 2
Completed	`NCT02596321` - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma	Phase 3
Completed	`NCT02279706` - Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test	N/A
Completed	`NCT01971086` - Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary	N/A
Completed	`NCT01771120` - Control and Burden of Asthma and Rhinitis	N/A
Completed	`NCT01469234` - A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)	Phase 4
Withdrawn	`NCT01177852` - Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis	Phase 3
Completed	`NCT02879929` - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction	N/A
Completed	`NCT00724698` - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria