Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber

NCT03496103 | Completed Phase 1

• 1 other identifier: Pollen Exposure Chamber
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  3 hours

Study Arms (2)

Allergic Subjects

OTHER

After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded

Biological: ragweed pollen

Healthy

OTHER

After recording baseline symptoms, subjects were exposed to ragweed pollen for three hours and symptoms were recorded

Biological: ragweed pollen

Interventions

ragweed pollen BIOLOGICAL

three hours ragweed pollen in a allergen exposure chamber

Allergic Subjects; Healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

ragweed pollen

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sanjiv Sur, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking Details: Investigator received de-identified biological material for further studies.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 12, 2018
• Study Start: February 29, 2016
• Primary Completion: March 12, 2016
• Study Completion: March 12, 2016
• Last Updated: April 12, 2018

Record last verified: 2018-04