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

Primary Purpose

Hypersensitivity, Immediate

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nasal Allergen Challenge
Environmental Exposure Chamber
Cat allergen (FelD1)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypersensitivity, Immediate focused on measuring Cat Allergy, Feld1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of moderate to severe allergic rhinitis (AR) caused by cat exposure for at least 2 years.
  2. Skin prick test mean wheal diameter ≥ 5 mm larger than negative control to standardized cat extract at screening.
  3. 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.
  4. In general good health based on medical history and physical exam.
  5. The ability to give informed consent and comply with study procedures.

Exclusion Criteria:

  1. A history of anaphylaxis to cat allergen.
  2. Prebronchodilator FEV1 less than 80% of predicted value at screening visit.
  3. 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.)
  4. 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.
  5. 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.
  6. History of serious chronic medical conditions which might interfere with treatment or assessments or may pose additional risks from participation in the study.
  7. History of chronic obstructive pulmonary disease (COPD).
  8. History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
  9. 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.
  10. 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.
  11. Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge.
  12. Exposure to an individual with active tuberculosis within six months prior to allergen challenge.
  13. At time of allergen challenge, current symptoms of, or treatment for, an upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
  14. 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.
  15. Any tobacco smoking within the last year or a history of ≥10 pack years.
  16. Allergen immunotherapy treatment with cat within the previous 5 years.
  17. Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading criteria.
  18. History of bleeding disorders, treatment with anticoagulation or anti-platelet therapy or chronic treatment with aspirin for cardiovascular prophylaxis.
  19. Treatment with omalizumab within 6 months prior to the NAC or EEC procedures.
  20. Currently taking any of the following medications: beta blockers; tricyclic antidepressants; monoamine oxidase inhibitors.
  21. Ongoing systemic immunosuppressive treatment.
  22. History of intolerance to rescue medications or their excipients.
  23. For women of childbearing age a positive urine pregnancy test with sensitivity of less than 50 mIU/mL.
  24. The use of any investigational drug within 30 days of the NAC or EEC procedures.
  25. The presence of any medical condition that the investigator deems incompatible with participation in the trial.
  26. Any clinically significant abnormal finding on physical examination, vital signs or laboratory results at screening as deemed so by the Investigator.
  27. Any clinically significant physical findings of nasal anatomical deformities (including the presence of nasal mucosal ulceration, nasal polyps, purulent secretions, septal perforation or any other major abnormalities in the nose) which, at the discretion of the Investigator, would interfere with the study procedures.

Sites / Locations

  • Inflamax Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NAC Followed by EEC

EEC Followed by NAC

Dose-finding Phase

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC)
TNSS AUC evaluated from hour 0 to hour 3 of the NAC
EEC TNSS AUC
TNSS AUC evaluated from hour 0 to hour 3 of the EEC

Secondary Outcome Measures

TNSS AUC with NAC
TNSS AUC with EEC
Recorded on second day of EEC.
Peak TNSS Score
Peak TNSS score during NAC and EEC.

Full Information

First Posted
June 11, 2014
Last Updated
September 8, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)
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1. Study Identification

Unique Protocol Identification Number
NCT02163122
Brief Title
Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC)
Official Title
A Pilot Study to Compare Responses to Cat Allergen Exposure Using the Environmental Exposure Chamber (EEC) and Nasal Allergen Challenge (NAC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity, Immediate
Keywords
Cat Allergy, Feld1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAC Followed by EEC
Arm Type
Experimental
Arm Description
This arm will undergo allergy assessment first by NAC. After a rest and washout period, the same individuals will undergo assessment in an EEC.
Arm Title
EEC Followed by NAC
Arm Type
Experimental
Arm Description
This arm will undergo allergy assessment first in an EEC. After a rest and washout period, the same individuals will undergo assessment by NAC.
Arm Title
Dose-finding Phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nasal Allergen Challenge
Intervention Description
Cat allergen (FelD1) applied directly to the nasal tissues
Intervention Type
Other
Intervention Name(s)
Environmental Exposure Chamber
Other Intervention Name(s)
EEC
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Cat allergen (FelD1)
Primary Outcome Measure Information:
Title
NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC)
Description
TNSS AUC evaluated from hour 0 to hour 3 of the NAC
Time Frame
Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 30 (for "EEC first" arm)
Title
EEC TNSS AUC
Description
TNSS AUC evaluated from hour 0 to hour 3 of the EEC
Time Frame
Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm)
Secondary Outcome Measure Information:
Title
TNSS AUC with NAC
Time Frame
Hour 0 to Hour 2
Title
TNSS AUC with EEC
Description
Recorded on second day of EEC.
Time Frame
Hour 1 to Hour 3
Title
Peak TNSS Score
Description
Peak TNSS score during NAC and EEC.
Time Frame
Hour 0 to Hour 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. At time of allergen challenge, current symptoms of, or treatment for, an upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve. 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. Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading criteria. History of bleeding disorders, treatment with anticoagulation or anti-platelet therapy or chronic treatment with aspirin for cardiovascular prophylaxis. Treatment with omalizumab within 6 months prior to the NAC or EEC procedures. Currently taking any of the following medications: beta blockers; tricyclic antidepressants; monoamine oxidase inhibitors. Ongoing systemic immunosuppressive treatment. History of intolerance to rescue medications or their excipients. For women of childbearing age a positive urine pregnancy test with sensitivity of less than 50 mIU/mL. The use of any investigational drug within 30 days of the NAC or EEC procedures. The presence of any medical condition that the investigator deems incompatible with participation in the trial. Any clinically significant abnormal finding on physical examination, vital signs or laboratory results at screening as deemed so by the Investigator. Any clinically significant physical findings of nasal anatomical deformities (including the presence of nasal mucosal ulceration, nasal polyps, purulent secretions, septal perforation or any other major abnormalities in the nose) which, at the discretion of the Investigator, would interfere with the study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Durham, MD
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Piyush Patel, MD
Organizational Affiliation
Inflamax Research Incorporated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inflamax Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1A4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21848757
Citation
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.
Results Reference
background
Links:
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT) website
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID) website
URL
http://www.immunetolerance.org
Description
Immune Tolerance Network (ITN) website

Learn more about this trial

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

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