Allergic RhinitisPhase 1PollenNCT03496103
Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber
A Phase 1 study testing ragweed pollen in people with Allergic Rhinitis, run by The University of Texas Medical Branch, Galveston.
Trial summary
In this study subjects self recorded nasal and ocular symptoms scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal allergic rhinitis was designed to enroll up to 35 participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ragweed pollen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 12 Mar 2016
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
- Male or Female, 18 to 70 years of age, at time of the Screening visit.
- Positive allergic participants must have a history of at least moderate AR due to hypersensitivity to ragweed pollen for a minimum of 2 years prior to the Screening visit.
- Positive allergic participants must respond to the ragweed pollen through a standard SPT administered at the Screening visit. A positive SPT is defined as a specified aeroallergen wheal diameter of at least 5 mm or larger than the negative control (normal saline). A historical SPT performed within three-hundred sixty-five (365) days or one (1) year will be accepted in lieu of performing a new SPT.
- Normal negative control participants must have no medical history suggestive of chronic or recurrent nasal and ocular symptoms secondary to allergy to the ragweed pollen.
- Normal negative control participants must demonstrate a negative SPT to the ragweed pollen at the Screening visit. A historical SPT performed within three-hundred sixty-five (365) days or one (1) year will be accepted in lieu of performing a new SPT.
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- Subject understands and is willing, able and likely to comply with study procedures and restrictions.
- Subject, if female of child bearing potential, must have a negative urine pregnancy test at Visit 1. All females of child bearing potential must agree to a medically acceptable form of birth control throughout the study duration and for at least 1 month prior to Visit 1. Acceptable methods of birth control for this study include:
- oral, patch, or intra-vaginal contraceptives
- Norplant System®
- Depo-Provera®
- Intrauterine device (IUD)
- double barrier method
- abstinence
- surgically sterile females (hysterectomy or tubal ligation)
- > 1 year post-menopausal females
- abstinence
- Other than SAR, participant is healthy as determined by pre-study medical history, physical examination and vital signs. Any chronic conditions that may interfere with the study outcomes or the subject's safety will be considered clinically significant and a reason for exclusion.
- Subject must be able to read, comprehend, and record all information in English.
Who cannot join
- Has significant current nasal or ocular symptoms that the study doctor associates with perennial allergic or non-allergic rhinitis.
- Female participant who is pregnant or lactating.
- Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes a clinically relevant medical or surgical history or presence of other respiratory disease (exceptions made for asthma and AR as defined in further exclusion criteria), or gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, immunological, dermatological, connective tissue diseases or disorders, or a history of malignancy within the past 5 years, with the exception of non- melanoma skin cancer.
- Has any significant abnormalities found during physical exam as determined by the investigator.
- Has had a respiratory and/or bacterial sinusitis infection during the past one (1) week prior to the first challenge visit or any subsequent study visits.
- Has a current medical history of significant pulmonary disease and/or active asthma requiring daily drug therapy. Mild, intermittent asthma is permitted (managed with short acting beta-agonist less than 3 times per week). Isolated exercise-induced bronchospasm is also permitted.
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- Has received an investigational drug within the last thirty (30) days.
- Has a history of rebound nasal congestion from extended use of topical decongestants.
- Has had use of immunotherapy containing short ragweed within the last 3 years.
- Has a history of nasal polyps, nasal septal perforation, or nasal tract malformations as noted on physical exam.
- Has a clinically significant history of substance abuse, drug addiction, or alcohol abuse in the past 3 years in the judgement of the investigator.
- Currently uses or is expected to use any of the disallowed medications as listed in Disallowed Medications in section 4.3.
- Cannot communicate reliably with the investigator.
- Is unlikely to cooperate with the requirements of the study.
- -
About this study
Official title: Induction of Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber
In this study subjects self recorded nasal and ocular symptoms scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal allergic rhinitis was designed to enroll up to 35 participants. These participants would be age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2 phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen for up to 180 minutes.
Read the detailed description
This was a study to evaluate self recorded nasal and ocular allergy symptom scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal allergic rhinitis was designed to enroll up to 35 participants. These participants would be age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2 phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen for up to 180 minutes. For allergic participants, qualification symptom scores at 120 minutes of exposure determined if ACC exposure would be continued.
- Conditions
- Allergic Rhinitis
- Being tested
- ragweed pollen
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ragweed pollenBiological
three hours ragweed pollen in a allergen exposure chamber
| Study group | Role | What they receive |
|---|---|---|
| Allergic Subjects | Other | After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded Receives: Biological: ragweed pollen |
| Healthy | Other | After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded Receives: Biological: ragweed pollen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ragweed pollen exposure
Subjects self-recorded nasal allergy symptom scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). The subjects self-assessed total nasal symptom scores, a combination or runny nose, itchy nose, sneezing and nasal congestion on a scale of 0-3 using the Likert 4-point severity score: 0=none, 1=minimal, 2=moderate, 3=severe symptoms
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start29 Feb 2016
- Primary completion12 Mar 2016
- Study completion12 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy non allergic and ragweed allergic subjects were exposed to ragweed pollen in a pollen exposure chamber for 3 hrs and symptom score was recorded
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv Sur, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496103
- Sponsor's protocol ID
- Pollen Exposure Chamber
- Acronym
- Pollen
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber
- ClinicalTrials.gov ID
- NCT03496103
- Acronym / sponsor ID
- Pollen / Pollen Exposure Chamber
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 12 Mar 2016 (actual)
- Study completion
- 12 Mar 2016 (actual)
- First posted
- 12 Apr 2018 (actual)
- 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.
In this study subjects self recorded nasal and ocular symptoms scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal allergic rhinitis was designed to enroll up to 35 participants. These participants would be age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2 phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen for up to 180 minutes.
Detailed description
This was a study to evaluate self recorded nasal and ocular allergy symptom scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal allergic rhinitis was designed to enroll up to 35 participants. These participants would be age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2 phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen for up to 180 minutes. For allergic participants, qualification symptom scores at 120 minutes of exposure determined if ACC exposure would be continued.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
- Model description
- Healthy non allergic and ragweed allergic subjects were exposed to ragweed pollen in a pollen exposure chamber for 3 hrs and symptom score was recorded
| Arm | Type | Receives |
|---|---|---|
| Allergic Subjects | Other | Biological: ragweed pollenAfter recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded |
| Healthy | Other | Biological: ragweed pollenAfter recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
- Male or Female, 18 to 70 years of age, at time of the Screening visit.
- Positive allergic participants must have a history of at least moderate AR due to hypersensitivity to ragweed pollen for a minimum of 2 years prior to the Screening visit.
- Positive allergic participants must respond to the ragweed pollen through a standard SPT administered at the Screening visit. A positive SPT is defined as a specified aeroallergen wheal diameter of at least 5 mm or larger than the negative control (normal saline). A historical SPT performed within three-hundred sixty-five (365) days or one (1) year will be accepted in lieu of performing a new SPT.
- Normal negative control participants must have no medical history suggestive of chronic or recurrent nasal and ocular symptoms secondary to allergy to the ragweed pollen.
Key exclusion criteria (15 listed)
- Has significant current nasal or ocular symptoms that the study doctor associates with perennial allergic or non-allergic rhinitis.
- Female participant who is pregnant or lactating.
- Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes a clinically relevant medical or surgical history or presence of other respiratory disease (exceptions made for asthma and AR as defined in further exclusion criteria), or gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, immunological, dermatological, connective tissue diseases or disorders, or a history of malignancy within the past 5 years, with the exception of non- melanoma skin cancer.
- Has any significant abnormalities found during physical exam as determined by the investigator.
- Has had a respiratory and/or bacterial sinusitis infection during the past one (1) week prior to the first challenge visit or any subsequent study visits.
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 |
|---|---|---|
| ragweed pollenthree hours ragweed pollen in a allergen exposure chamber | Biological | Allergic Subjects, Healthy |
Primary outcome
Effect of ragweed pollen exposure
Time frame: 3 hours
Subjects self-recorded nasal allergy symptom scores from exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). The subjects self-assessed total nasal symptom scores, a combination or runny nose, itchy nose, sneezing and nasal congestion on a scale of 0-3 using the Likert 4-point severity score: 0=none, 1=minimal, 2=moderate, 3=severe symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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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.
Sanjiv Sur, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ragweed pollen in people with Allergic Rhinitis, run by The University of Texas Medical Branch, Galveston.
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 19 inclusion and 15 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: finished, as of the sponsor's last update on 12 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of ragweed pollen exposure (time frame: 3 hours). 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 12 Apr 2018.