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Hypersensitivity, ImmediateEarly Phase 1NCT02163122

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

A Early Phase 1 study testing Nasal Allergen Challenge, Environmental Exposure Chamber and Cat allergen (FelD1) in people with Hypersensitivity, Immediate, run by National Institute of Allergy and Infectious Diseases (NIAID) 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

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypersensitivity, Immediate
What is being tested?
Nasal Allergen Challenge, Environmental Exposure Chamber and Cat allergen (FelD1)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
Jan 2015to Jun 2016
Phase
Early Phase 1
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of moderate to severe allergic rhinitis (AR) caused by cat exposure for at least 2 years.
  • Skin prick test mean wheal diameter ≥ 5 mm larger than negative control to standardized cat extract at screening.
  • 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.
  • In general good health based on medical history and physical exam.
  • The ability to give informed consent and comply with study procedures.

Who cannot join

  • A history of anaphylaxis to cat allergen.
  • Prebronchodilator FEV1 less than 80% of predicted value at screening visit.
  • 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.)
  • 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.
  • 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.
  • History of serious chronic medical conditions which might interfere with treatment or assessments or may pose additional risks from participation in the study.
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  • History of chronic obstructive pulmonary disease (COPD).
  • History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
  • 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.
  • 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.
  • Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge.
  • Exposure to an individual with active tuberculosis within six months prior to allergen challenge.
  • 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.
  • 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.
  • Any tobacco smoking within the last year or a history of ≥10 pack years.
  • Allergen immunotherapy treatment with cat within the previous 5 years.
  • Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading criteria.
  • History of bleeding disorders, treatment with anticoagulation or anti-platelet therapy or chronic treatment with aspirin for cardiovascular prophylaxis.
  • Treatment with omalizumab within 6 months prior to the NAC or EEC procedures.
  • Currently taking any of the following medications: beta blockers; tricyclic antidepressants; monoamine oxidase inhibitors.
  • Ongoing systemic immunosuppressive treatment.
  • History of intolerance to rescue medications or their excipients.
  • For women of childbearing age a positive urine pregnancy test with sensitivity of less than 50 mIU/mL.
  • The use of any investigational drug within 30 days of the NAC or EEC procedures.
  • The presence of any medical condition that the investigator deems incompatible with participation in the trial.
  • Any clinically significant abnormal finding on physical examination, vital signs or laboratory results at screening as deemed so by the Investigator.
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Inflamax Research Inc.

    Mississauga, Ontario, L4W 1A4

Other trials in Canada

About this study

Official title: A Pilot Study to Compare Responses to Cat Allergen Exposure Using the Environmental Exposure Chamber (EEC) and Nasal Allergen Challenge (NAC)

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.

Being tested
Nasal Allergen Challenge, Environmental Exposure Chamber, Cat allergen (FelD1)
Keywords
Cat Allergy, Feld1
Medical subject headings
Hypersensitivity, Immediate

What participants receive

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

  • Nasal Allergen ChallengeProcedure or surgery

    Cat allergen (FelD1) applied directly to the nasal tissues

  • Environmental Exposure ChamberOther

    Also called EEC

    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.

  • Cat allergen (FelD1)Biological

Study groups in NCT02163122
Study groupRoleWhat they receive
NAC Followed by EECExperimentalThis arm will undergo allergy assessment first by NAC. After a rest and washout period, the same individuals will undergo assessment in an EEC.
Receives: Procedure: Nasal Allergen Challenge; Other: Environmental Exposure Chamber; Biological: Cat allergen (FelD1)
EEC Followed by NACExperimentalThis arm will undergo allergy assessment first in an EEC. After a rest and washout period, the same individuals will undergo assessment by NAC.
Receives: Procedure: Nasal Allergen Challenge; Other: Environmental Exposure Chamber; Biological: Cat allergen (FelD1)
Dose-finding PhaseExperimentalAn 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.
Receives: Procedure: Nasal Allergen Challenge; Biological: Cat allergen (FelD1)

What is being measured

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

  1. NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC)

    TNSS AUC evaluated from hour 0 to hour 3 of the NAC

    Measured: Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 30 (for "EEC first" arm)

  2. EEC TNSS AUC

    TNSS AUC evaluated from hour 0 to hour 3 of the EEC

    Measured: Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm)

Secondary outcomes (3)

  1. TNSS AUC with NAC

    Measured: Hour 0 to Hour 2

  2. TNSS AUC with EEC

    Recorded on second day of EEC.

    Measured: Hour 1 to Hour 3

  3. Peak TNSS Score

    Peak TNSS score during NAC and EEC.

    Measured: Hour 0 to Hour 8

Timeline

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

  1. First posted13 Jun 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163122
Sponsor's protocol ID
DAIT ITN061AD
Status last verified
Sep 2017
First submitted
11 Jun 2014
Last updated
12 Sep 2017
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 21848757

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nasal Allergen Challenge, Environmental Exposure Chamber and Cat allergen (FelD1) in people with Hypersensitivity, Immediate, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 5 inclusion and 27 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 12 Sep 2017. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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)). The study lists 2 primary outcomes in all. 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 NCT02163122, which also lists 1 linked publication.

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 12 Sep 2017.

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