Clinical Validation of Birch Pollen in the EEU

NCT02351830 | Completed

• 1 other identifier: Birch Validation Study
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The EEU has proven effective in multiple studies evaluating various aspects of seasonal allergic rhinitis. All previous EEU clinical trials have utilized ragweed or grass pollen as the allergen of choice for dispersal, due to the local population, but many emerging treatments for allergic rhinitis are allergen specific, thus it is desirable to expand the repertoire of pollen selection for use in the EEU. Ragweed, grass and birch pollen have differing appearances and sizes but essentially, both have characteristics which promote the ability to keep the pollen grains suspended and hence, the ability to maintain proper concentrations within the EEU. Preliminary validation studies conducted in the EEU, absent of human volunteers, have confirmed our ability to release, disperse and maintain birch pollen concentrations in the EEU using the existing technology. This study aims to validate the use of birch pollen on a clinical scale. By adding non- allergic participants into the EEU, the investigators hope to determine if non-allergic persons exhibit differences at baseline in their "epigenetic biomarkers" from those who have pre-existing and established allergic airways inflammation.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Total Nasal Symptom Score from Baseline to each time point.

  Participants will assess their symptoms every 30 minutes during the 4-hour pollen exposure session and the sum of the 4 nasal symptoms (runny nose, stuffy nose, sneezing and itchy nose) which create the Total Nasal Symptom Score (TNSS)

  Second and Final Visit (4 hour pollen exposure)

Secondary Outcomes (4)

• Percentage of people achieving a TNSS of 6 or greater

  Second and Final Visit (4 hour pollen exposure)

• Percentage of people achieving a TRSS of 10 or greater

  Second and Final Visit (4 hour pollen exposure)

• Change in Total Rhinoconjunctivitis Symptom Score from Baseline to each time point.

  Second and Final Visit (4 hour pollen exposure)

• Change in Peak Nasal Expiratory Flow (PNIF) from baseline at each time point.

  Second and Final Visit (4 hour pollen exposure)

Interventions

Birch Pollen OTHER

Participants will be exposed to birch pollen to activate their allergy symptoms therefore validating the unit.

Nasal Brushing PROCEDURE

To assess allergic biomarkers participants will provide a nasal sample which will be collected using a cytobrush. This procedure will be performed twice; once at screening and once following pollen exposure in the EEU.

Eligibility Criteria

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

You may qualify if:

• minimum 2 year document history of rhinoconjunctivitis during typical tree pollen season (mid March to early May) OR completely non-atopic (allergic) to all environmental allergens.
• positive skin test to birch allergen OR negative skin test to a panel of allergens at screening.

You may not qualify if:

• participants with asthma.
• participant is pregnant, lactating or actively trying to conceive.
• participant is currently receiving allergen specific immunotherapy.

Sponsors & Collaborators

• Queen's University: lead
• University of British Columbia: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• Ellis AK, Soliman M, Steacy LM, Adams DE, Hobsbawn B, Walker TJ. Clinical validation of controlled exposure to birch pollen in the Environmental Exposure Unit (EEU). Allergy Asthma Clin Immunol. 2016 Oct 19;12:53. doi: 10.1186/s13223-016-0156-7. eCollection 2016.

  PMID: 27777594 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

PR-10 protein, walnut birch pollen

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne K Ellis, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Allergy & Immunology

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

CA (1)