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

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ClinicalTrials.gov Identifier: NCT02163122
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date September 12, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC) [ Time Frame: Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 30 (for "EEC first" arm) ]
    TNSS AUC evaluated from hour 0 to hour 3 of the NAC
  • EEC TNSS AUC [ Time Frame: Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm) ]
    TNSS AUC evaluated from hour 0 to hour 3 of the EEC
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC) [ Time Frame: Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 29 (for "EEC first" arm) ]
    TNSS AUC evaluated from hour 0 to hour 3 of the NAC
  • EEC TNSS AUC [ Time Frame: Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm) ]
    TNSS AUC evaluated from hour 0 to hour 3 of the EEC
Change History Complete list of historical versions of study NCT02163122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • TNSS AUC with NAC [ Time Frame: Hour 0 to Hour 2 ]
  • TNSS AUC with EEC [ Time Frame: Hour 1 to Hour 3 ]
    Recorded on second day of EEC.
  • Peak TNSS Score [ Time Frame: Hour 0 to Hour 8 ]
    Peak TNSS score during NAC and EEC.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC)
Official Title  ICMJE A Pilot Study to Compare Responses to Cat Allergen Exposure Using the Environmental Exposure Chamber (EEC) and Nasal Allergen Challenge (NAC)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hypersensitivity, Immediate
Intervention  ICMJE
  • Procedure: Nasal Allergen Challenge
    Cat allergen (FelD1) applied directly to the nasal tissues
  • Other: Environmental Exposure Chamber
    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.
    Other Name: EEC
  • Biological: Cat allergen (FelD1)
Study Arms  ICMJE
  • Experimental: NAC Followed by EEC
    This arm will undergo allergy assessment first by NAC. After a rest and washout period, the same individuals will undergo assessment in an EEC.
    Interventions:
    • Procedure: Nasal Allergen Challenge
    • Other: Environmental Exposure Chamber
    • Biological: Cat allergen (FelD1)
  • Experimental: EEC Followed by NAC
    This arm will undergo allergy assessment first in an EEC. After a rest and washout period, the same individuals will undergo assessment by NAC.
    Interventions:
    • Procedure: Nasal Allergen Challenge
    • Other: Environmental Exposure Chamber
    • Biological: Cat allergen (FelD1)
  • Experimental: Dose-finding Phase
    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.
    Interventions:
    • Procedure: Nasal Allergen Challenge
    • Biological: Cat allergen (FelD1)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2014)
32
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163122
Other Study ID Numbers  ICMJE DAIT ITN061AD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Immune Tolerance Network (ITN)
Investigators  ICMJE
Study Chair: Stephen Durham, MD Imperial College London
Principal Investigator: Piyush Patel, MD Inflamax Research Incorporated
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP