Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC)

NCT02163122 | Completed Early Phase 1 DMC

• 1 other identifier: DAIT ITN061AD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot trial in cat allergic participants, designed to compare allergic responses in each participant to a specific allergen by two methods of exposure. The methods of exposure to be used are: the environment exposure chamber (EEC) and nasal allergen challenge (NAC). Potential participants will be screened for evidence of cat allergy. Participants with a range of allergic sensitivities to cat allergen will be enrolled. To help ensure some breadth in the level of allergic sensitivity among participants, individuals with both high and low exposures to cat allergens in their daily lives will be enrolled.

Conditions

Hypersensitivity, Immediate

Keywords

Cat Allergy; Feld1

Outcome Measures

Primary Outcomes (2)

• NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC)

  TNSS AUC evaluated from hour 0 to hour 3 of the NAC

  Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 30 (for "EEC first" arm)

• EEC TNSS AUC

  TNSS AUC evaluated from hour 0 to hour 3 of the EEC

  Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm)

Secondary Outcomes (3)

• TNSS AUC with NAC

  Hour 0 to Hour 2

• TNSS AUC with EEC

  Hour 1 to Hour 3

• Peak TNSS Score

  Hour 0 to Hour 8

Study Arms (3)

NAC Followed by EEC

EXPERIMENTAL

This arm will undergo allergy assessment first by NAC. After a rest and washout period, the same individuals will undergo assessment in an EEC.

Procedure: Nasal Allergen Challenge; Other: Environmental Exposure Chamber; Biological: Cat allergen (FelD1)

EEC Followed by NAC

EXPERIMENTAL

This arm will undergo allergy assessment first in an EEC. After a rest and washout period, the same individuals will undergo assessment by NAC.

Procedure: Nasal Allergen Challenge; Other: Environmental Exposure Chamber; Biological: Cat allergen (FelD1)

Dose-finding Phase

EXPERIMENTAL

An initial group of 6 to 12 participants with cat allergy as defined by the eligibility criteria will undergo a single-visit, stepwise dose-escalating nasal allergen challenge only, with the aim of estimating the most appropriate single dose of allergen to use in the randomized phase. Eligible participants who participate in the dose-finding phase may proceed to the randomized phase of the trial after a minimum 28-day washout period.

Procedure: Nasal Allergen Challenge; Biological: Cat allergen (FelD1)

Interventions

Nasal Allergen Challenge PROCEDURE

Cat allergen (FelD1) applied directly to the nasal tissues

Dose-finding Phase; EEC Followed by NAC; NAC Followed by EEC

Environmental Exposure Chamber OTHER

The mobile EEC (mEEC) is a movable facility, designed with clean-room technology, used to expose subjects to aeroallergens (in this trial, the allergen FelD1 from cats) at controlled, consistent airborne levels, similar to that experienced in subjects' daily lives.

Also known as: EEC

EEC Followed by NAC; NAC Followed by EEC

Cat allergen (FelD1) BIOLOGICAL

Dose-finding Phase; EEC Followed by NAC; NAC Followed by EEC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of moderate to severe allergic rhinitis (AR) caused by cat exposure for at least 2 years.
• Skin prick test mean wheal diameter ≥ 5 mm larger than negative control to standardized cat extract at screening.
• Non-pregnant, non-lactating women. For women of childbearing age, a willingness to use an effective form of contraception for the duration of the trial.
• In general good health based on medical history and physical exam.
• The ability to give informed consent and comply with study procedures.

You may not qualify if:

• A history of anaphylaxis to cat allergen.
• Prebronchodilator FEV1 less than 80% of predicted value at screening visit.
• History of moderate/severe ARIA (Allergic Rhinitis and its Impact on Asthma) severity classification for allergic rhinitis for most of previous year in the absence of cat exposure (ARIA classification citation: Bousquet J, Khaltaev N, Cruz AA, et al. Allergy 2008; 63 Suppl 86:8-160.)
• History of asthma symptoms or exacerbations in the past 12 months requiring regular inhaled corticosteroids for greater than 4 weeks per year, any oral corticosteroid usage, any emergency department visit for asthma or any asthma-related hospitalization.
• Participants who, at the discretion of the investigator, suffer from seasonal allergic rhinitis to interfering allergens that cannot complete the study outside of the local pollen season or who have significant allergy to other perennial allergens that cannot be avoided during the study.
• History of serious chronic medical conditions which might interfere with treatment or assessments or may pose additional risks from participation in the study.
• History of chronic obstructive pulmonary disease (COPD).
• History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
• History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
• History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency, where, in the opinion of the study physician, participation in the trial would pose a risk or significant effect on the immune system.
• Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge.
• Exposure to an individual with active tuberculosis within six months prior to allergen challenge.
• History of cancer within the last 5 years, except for nonmelanoma skin cancer, stage 1 renal cell carcinoma, stage 1 prostate cancers cured by local resection and any curatively treated carcinomas in situ.
• Any tobacco smoking within the last year or a history of ≥10 pack years.
• Allergen immunotherapy treatment with cat within the previous 5 years.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

Related Publications (1)

• Walker SM, Durham SR, Till SJ, Roberts G, Corrigan CJ, Leech SC, Krishna MT, Rajakulasingham RK, Williams A, Chantrell J, Dixon L, Frew AJ, Nasser SM; British Society for Allergy and Clinical Immunology. Immunotherapy for allergic rhinitis. Clin Exp Allergy. 2011 Sep;41(9):1177-200. doi: 10.1111/j.1365-2222.2011.03794.x.

  PMID: 21848757 BACKGROUND

Related Links

• Division of Allergy, Immunology, and Transplantation (DAIT) website
• National Institute of Allergy and Infectious Diseases (NIAID) website
• Immune Tolerance Network (ITN) website

MeSH Terms

Conditions

Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases

Study Officials

• Stephen Durham, MD

  Imperial College London

  STUDY CHAIR

• Piyush Patel, MD

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

CA (1)