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Allergic RhinitisNECNCT03414801

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

A study testing Allergen Exposure in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Red Maple Trials Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Allergic Rhinitis, Rhinoconjunctivitis, Exposure
What is being tested?
Allergen Exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
6 Feb 2018to 30 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1G6C6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Allergen Exposure
Keywords
Environmental Exposure Unit, Cat Allergen, Rhinitis, Subject Validation
Medical subject headings
Rhinitis, Allergic, Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allergen ExposureOther

    Also called Environmental 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.

Study groups in NCT03414801
Study groupRoleWhat they receive
Cohort 1Active comparatorCat Allergic Subjects
Receives: Other: Allergen Exposure
Cohort 2Active comparatorNon-Allergic Subjects will
Receives: Other: Allergen Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Runny nose, sneezing, blocked nose, itchy nose

    Measured: 15 weeks

Secondary outcomes (8)

  1. TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects

    Measured: 15 weeks

  2. Difference in exposure time between the two exposure days for all subjects

    Measured: 15 weeks

  3. Comparison of the exposure times of allergic compared to non-allergic subjects

    Measured: 15 weeks

  4. Comparison of TNSS at individual time points on the two exposure days

    Runny nose, sneezing, blocked nose, itchy nose

    Measured: 15 weeks

  5. Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days

    Wheezing, shortness of breath, coughing

    Measured: 15 weeks

  6. Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days

    Sum of TNSS and TOSS

    Measured: 15 weeks

  7. Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days

    Itchy eyes and watery eyes

    Measured: 15 weeks

  8. Comparison of Fel d1 levels during the exposures

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start6 Feb 2018
  3. Primary completion15 Apr 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414801
Sponsor's protocol ID
RMT005
Acronym
NEC
Status last verified
Apr 2018
First submitted
18 Jan 2018
Last updated
24 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Allergen Exposure in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Red Maple Trials Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03414801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.

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