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Repeat Dose Nasal Allergen Challenge

NCT ID: NCT01110837

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-04-30

Brief Summary

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What happens in the nose during an allergic reaction? Are there changes that a new drug could treat? What is the best way to test new drugs?The response of the nose to being exposed to cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell and chemical changes that occur in the nose will be studied before and after being exposed to cat allergen. The investigators will also to see if giving repeated doses of allergen increases the response.Allergic rhinitis is a very common illness. There are over 500 million patients worldwide. It can increase the severity of associated asthma. Currently available drugs do not completely treat the symptoms. New treatments need to be found. A way of testing these drugs is very important. This study will investigate causes of the symptoms that occur in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study Hypothesis is that a model of nasal allergen challenge shows an increased response (priming) with repeat challenges as determined by changes in nasal peak inspiratory flow.

Detailed Description

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Conditions

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Allergic Rhinitis

Keywords

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Allergic rhinitis Allergen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Allergen

Group Type ACTIVE_COMPARATOR

Allergen

Intervention Type OTHER

Allergen nasal challenge

Placebo

Group Type PLACEBO_COMPARATOR

Placebo challenge

Intervention Type OTHER

Placebo nasal challenge

Interventions

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Allergen

Allergen nasal challenge

Intervention Type OTHER

Placebo challenge

Placebo nasal challenge

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects aged over 18 able to understand and sign the written consent form.
2. Able to comply with study procedures and protocol.
3. Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit.
4. Clear history of nasal symptoms on exposure to cats.
5. Otherwise healthy with no other health problems, other than mild asthma controlled by intermittent β2-agonist use, that may prevent the subject participating in the study.

Exclusion Criteria

1. Presence of perennial rhinitis or seasonal allergic rhinitis.
2. TNSS \< 2 at screening
3. Viral URTI within the 2 weeks prior to screening.
4. Current smoker or history of smoking within the previous 3 months.
5. Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
6. Use of concomitant medication that could affect responses to nasal challenge (e.g. corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
7. Participation in any other clinical trials within the previous 3 months.
8. Use of inhaled corticosteroids within the 2 months prior to screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helen Neighbour, MB BS

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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St Joseph's Healthcare

Hamitlon, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Helen Neighbour, MB BS PhD

Role: CONTACT

Phone: 905-522-1155

Email: [email protected]

Other Identifiers

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#09-3232

Identifier Type: -

Identifier Source: org_study_id