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

August 23, 2018 updated by: Red Maple Trials Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1G6C6
        • Ottawa Allergy Research Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Environmental Exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
15 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects
Time Frame: 15 weeks
15 weeks
Difference in exposure time between the two exposure days for all subjects
Time Frame: 15 weeks
15 weeks
Comparison of the exposure times of allergic compared to non-allergic subjects
Time Frame: 15 weeks
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
15 weeks
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
15 weeks
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
15 weeks
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
15 weeks
Comparison of Fel d1 levels during the exposures
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Red Maple Trials Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ottawa Allergy Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMT005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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