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Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects (NEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03414801
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Ottawa Allergy Research Corporation
Information provided by (Responsible Party):
Red Maple Trials Inc.

Brief Summary:
To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Rhinoconjunctivitis Exposure Other: Allergen Exposure Not Applicable

Detailed Description:
To validate the Red Maple Trials Natural Exposure Chamber for cat exposure studies in non-asthmatic subjects with perennial allergic rhinitis and allergy to cat dander by examining the reproducibility of the response on two allergen challenge days and comparing the response of allergic to non-allergic subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-Group Study Evaluating Reproducibility of Rhinitis Symptoms Induced by Cat Allergen (Fel d1) Exposure in the Red Maple Trials Natural Exposure Chamber (NEC) ™ in Subjects With Cat Allergy
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : July 30, 2018

Arm Intervention/treatment
Active Comparator: Cohort 1
Cat Allergic Subjects
Other: Allergen Exposure
Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.
Other Name: Environmental Exposure

Active Comparator: Cohort 2
Non-Allergic Subjects will
Other: Allergen Exposure
Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.
Other Name: Environmental Exposure




Primary Outcome Measures :
  1. Difference in Total Nasal Symptom Score (TNSS) change from baseline to the end of the challenge between the two challenge days (Visits 2 and 3) in the cat-allergic subjects [ Time Frame: 15 weeks ]
    Runny nose, sneezing, blocked nose, itchy nose


Secondary Outcome Measures :
  1. TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects [ Time Frame: 15 weeks ]
  2. Difference in exposure time between the two exposure days for all subjects [ Time Frame: 15 weeks ]
  3. Comparison of the exposure times of allergic compared to non-allergic subjects [ Time Frame: 15 weeks ]
  4. Comparison of TNSS at individual time points on the two exposure days [ Time Frame: 15 weeks ]
    Runny nose, sneezing, blocked nose, itchy nose

  5. Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days [ Time Frame: 15 weeks ]
    Wheezing, shortness of breath, coughing

  6. Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days [ Time Frame: 15 weeks ]
    Sum of TNSS and TOSS

  7. Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days [ Time Frame: 15 weeks ]
    Itchy eyes and watery eyes

  8. Comparison of Fel d1 levels during the exposures [ Time Frame: 15 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Allergic Subjects:

  • Male and female adults, 18 years to 65 years of age
  • Willing and able to give informed consent for participation in the study.
  • Otherwise healthy with a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years
  • With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal ≥3 mm larger than the negative control performed at the screening visit or within 6 months of the screening visit provided that complete documentation (specific allergen used for the SPT and the size of the reaction) is available
  • Having sufficient rhinoconjunctivitis symptoms (TRCSS score ≥5) during the first cat challenge
  • If subjects are taking medications (other than allergy medications), the dosing must be stable for at least 4 weeks prior to study entry
  • With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study
  • Able (in the investigators opinion) and willing to comply with all study requirements

Exclusion Criteria for Allergic Subjects:

  • Subjects with a cat at home or who are regularly exposed to cats during the study period
  • Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only
  • Subjects with a history of anaphylactic reactions defined as previous or current presentation with two or more of the following:

    • Involvement of the skin or mucosa
    • respiratory difficulties
    • low blood pressure
    • gastrointestinal symptoms
  • Subjects who have undergone allergen desensitization for cat allergy within the last 2 years
  • Subjects with structural nasal defects or nasal polyps
  • Subjects with a positive skin-prick test reaction to house dust mite
  • Subjects having an infection of the upper airways within 2 weeks prior to the screening visit.
  • Subjects who develop an upper respiratory tract infection during the study will be discontinued
  • Subjects who have received treatment with Xolair or immunosuppressants during the 4 months prior to the screening visit
  • Subjects who wear contact lenses will not be permitted to wear them during the challenge sessions
  • Female subjects who are pregnant or lactating at screening or who are planning pregnancy during the course of the study
  • Subjects with significant renal or hepatic impairment at screening
  • Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study
  • Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study
  • Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit
  • Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)
  • Subjects with a history of alcohol or drug abuse within the previous 5 years
  • Subjects with known HIV or hepatitis B or C positivity
  • Subjects who for any reason would be unlikely to comply with the study requirements

Inclusion Criteria for non allergic subjects:

  • Healthy male and female adults, 18 years to 65 years of age
  • Willing and able to give informed consent for participation in the study.
  • With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study
  • Able (in the investigators opinion) and willing to comply with all study requirements

Exclusion Criteria for non allergic subjects:

  • With a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years
  • With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal ≥3 mm larger than the negative control performed at the screening visit
  • Subjects with a cat at home or who are regularly exposed to cats during the study period
  • Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only
  • Subjects with a history of anaphylactic reactions defined as previous or current presentation with two or more of the following:

    • Involvement of the skin or mucosa
    • respiratory difficulties
    • low blood pressure
    • gastrointestinal symptoms
  • Subjects with structural nasal defects or nasal polyps
  • Subjects with a positive skin-prick test reaction to house dust mite
  • Subjects having an infection of the upper airways within 2 weeks prior to the screening visit.
  • Subjects who develop an upper respiratory tract infection during the study will be discontinued
  • Subjects who have received treatment with Xolair or immunosuppressants during the 4 months prior to the screening visit
  • Subjects who wear contact lenses will not be permitted to wear them during the challenge sessions
  • Female subjects who are pregnant or lactating at screening or who are planning pregnancy during the course of the study
  • Subjects with significant renal or hepatic impairment at screening
  • Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study
  • Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study
  • Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit
  • Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)
  • Subjects with a history of alcohol or drug abuse within the previous 5 years
  • Subjects with known HIV or hepatitis B or C positivity
  • Subjects who for any reason would be unlikely to comply with the study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414801


Locations
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Canada, Ontario
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1G6C6
Sponsors and Collaborators
Red Maple Trials Inc.
Ottawa Allergy Research Corporation

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Responsible Party: Red Maple Trials Inc.
ClinicalTrials.gov Identifier: NCT03414801     History of Changes
Other Study ID Numbers: RMT005
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Red Maple Trials Inc.:
Environmental Exposure Unit
Cat Allergen
Rhinitis
Subject Validation

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases