Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber (Pollen)

April 11, 2018 updated by: The University of Texas Medical Branch, Galveston

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
  2. Male or Female, 18 to 70 years of age, at time of the Screening visit.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Subject understands and is willing, able and likely to comply with study procedures and restrictions.

  8. 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:

    1. oral, patch, or intra-vaginal contraceptives
    2. Norplant System®
    3. Depo-Provera®
    4. Intrauterine device (IUD)
    5. double barrier method
    6. abstinence
    7. surgically sterile females (hysterectomy or tubal ligation)
    8. > 1 year post-menopausal females
    9. abstinence
  9. 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.
  10. Subject must be able to read, comprehend, and record all information in English.

Exclusion Criteria:

  1. Has significant current nasal or ocular symptoms that the study doctor associates with perennial allergic or non-allergic rhinitis.
  2. Female participant who is pregnant or lactating.
  3. 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.
  4. Has any significant abnormalities found during physical exam as determined by the investigator.
  5. 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.
  6. 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.
  7. Has received an investigational drug within the last thirty (30) days.
  8. Has a history of rebound nasal congestion from extended use of topical decongestants.
  9. Has had use of immunotherapy containing short ragweed within the last 3 years.
  10. Has a history of nasal polyps, nasal septal perforation, or nasal tract malformations as noted on physical exam.
  11. Has a clinically significant history of substance abuse, drug addiction, or alcohol abuse in the past 3 years in the judgement of the investigator.
  12. Currently uses or is expected to use any of the disallowed medications as listed in Disallowed Medications in section 4.3.
  13. Cannot communicate reliably with the investigator.

  14. Is unlikely to cooperate with the requirements of the study.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Allergic Subjects
After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded
Biological: ragweed pollen
three hours ragweed pollen in a allergen exposure chamber
Other: Healthy
After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded
Biological: ragweed pollen
three hours ragweed pollen in a allergen exposure chamber

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanjiv Sur, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pollen Exposure Chamber

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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