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

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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.

Tracking Information
First Submitted Date  ICMJE January 18, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date April 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03414801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects [ Time Frame: 15 weeks ]
  • Difference in exposure time between the two exposure days for all subjects [ Time Frame: 15 weeks ]
  • Comparison of the exposure times of allergic compared to non-allergic subjects [ Time Frame: 15 weeks ]
  • Comparison of TNSS at individual time points on the two exposure days [ Time Frame: 15 weeks ]
    Runny nose, sneezing, blocked nose, itchy nose
  • 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
  • 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
  • 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
  • Comparison of Fel d1 levels during the exposures [ Time Frame: 15 weeks ]
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 Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Allergic Rhinitis
  • Rhinoconjunctivitis
  • Exposure
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Cohort 1
    Cat Allergic Subjects
    Intervention: Other: Allergen Exposure
  • Active Comparator: Cohort 2
    Non-Allergic Subjects will
    Intervention: Other: Allergen Exposure
Publications * Not Provided

*   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: January 26, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date April 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03414801
Other Study ID Numbers  ICMJE RMT005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Red Maple Trials Inc.
Study Sponsor  ICMJE Red Maple Trials Inc.
Collaborators  ICMJE Ottawa Allergy Research Corporation
Investigators  ICMJE Not Provided
PRS Account Red Maple Trials Inc.
Verification Date April 2018

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