RhinitisNCT02949050
Corn Occupational Rhinitis SCIT Efficacy Study
A study testing subcutaneous allergen immunotherapy (SCIT) and SCIT in people with Rhinitis, run by United Allergy Services.
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. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis
- What is being tested?
- subcutaneous allergen immunotherapy (SCIT) and SCIT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Negative allergy test to corn pollen,
- Not residing on/near farm growing corn,
- An initial symptom score of < 9.
About this study
Official title: Corn Based Occupational Rhinitis; SCIT Efficacy Study
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.
Read the 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.
- Conditions
- Rhinitis
- Being tested
- subcutaneous allergen immunotherapy (SCIT), SCIT
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
SCITBiological
Treatment group consists of patients who completed > 1 year of SCIT while control group patients did not undergo SCIT
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | the treatment -patients underwent SCIT and antihistamine/nasal steroid/use. Receives: Biological: subcutaneous allergen immunotherapy (SCIT); Biological: SCIT |
| Control Group | No intervention | Control patient group only used antihistamines/nasal steroids but no SCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
secondary outcome measure-completed quality of life surveys will be assessed from before to after therapy and between the treatment and control groups.
Measured: Actual survey completions take less than 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Allergy Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- frederick m schaffer, md, Principal investigator, United Allergy Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949050
- Sponsor's protocol ID
- Corn SCIT study-1
- Status last verified
- Oct 2017
- First submitted
- 29 Aug 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corn Based Occupational Rhinitis; SCIT Efficacy Study
- ClinicalTrials.gov ID
- NCT02949050
- Acronym / sponsor ID
- Corn SCIT study-1
- Conditions
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- United Allergy ServicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: subcutaneous allergen immunotherapy (SCIT), Biological: SCITthe treatment -patients underwent SCIT and antihistamine/nasal steroid/use. |
| Control Group | No intervention | –Control patient group only used antihistamines/nasal steroids but no SCIT |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Negative allergy test to corn pollen,
- Not residing on/near farm growing corn,
- An initial symptom score of < 9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Treatment Group |
| SCITTreatment group consists of patients who completed > 1 year of SCIT while control group patients did not undergo SCIT | Biological | Treatment Group |
Primary outcome
Corn based Occupational Rhinitis symptom and medication score surveys
Time frame: prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys.
The completed symptom and medication score surveys will be contrasted from before to after therapy and between treatment and control groups.
1 secondary outcome
Corn based Occupational Rhinitis quality of life surveys
Time frame: Actual survey completions take less than 1 day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
frederick m schaffer, md principal investigator
United Allergy Services
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous allergen immunotherapy (SCIT) and SCIT in people with Rhinitis, run by United Allergy Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corn based Occupational Rhinitis symptom and medication score surveys (time frame: prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.