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Repeat Dose Nasal Allergen Challenge

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Allergen

Placebo challenge

About this trial

This is an interventional basic science trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Allergen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects aged over 18 able to understand and sign the written consent form.
Able to comply with study procedures and protocol.
Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit.
Clear history of nasal symptoms on exposure to cats.
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:

Presence of perennial rhinitis or seasonal allergic rhinitis.
TNSS < 2 at screening
Viral URTI within the 2 weeks prior to screening.
Current smoker or history of smoking within the previous 3 months.
Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
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.
Participation in any other clinical trials within the previous 3 months.
Use of inhaled corticosteroids within the 2 months prior to screening.

Sites / Locations

St Joseph's HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allergen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in peak nasal inspiratory flow following repeat allergen challenge

The peak nasal inspiratory flow will be measured using a hand-held peak flow meter, and changes will be measured following repeated allergen challenge.

Secondary Outcome Measures

Full Information

NCT ID

NCT01110837

First Posted

April 23, 2010

Last Updated

October 31, 2012

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT01110837

Brief Title

Repeat Dose Nasal Allergen Challenge

Official Title

Repeat Dose Nasal Allergen Challenge: Development of a Model to Investigate the Cellular and Inflammatory Changes That Occur in Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic rhinitis, Allergen

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Allergen

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Allergen

Intervention Description

Allergen nasal challenge

Intervention Type

Other

Intervention Name(s)

Placebo challenge

Intervention Description

Placebo nasal challenge

Primary Outcome Measure Information:

Title

Change in peak nasal inspiratory flow following repeat allergen challenge

Description

The peak nasal inspiratory flow will be measured using a hand-held peak flow meter, and changes will be measured following repeated allergen challenge.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged over 18 able to understand and sign the written consent form. Able to comply with study procedures and protocol. Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit. Clear history of nasal symptoms on exposure to cats. 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: Presence of perennial rhinitis or seasonal allergic rhinitis. TNSS < 2 at screening Viral URTI within the 2 weeks prior to screening. Current smoker or history of smoking within the previous 3 months. Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months. 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. Participation in any other clinical trials within the previous 3 months. Use of inhaled corticosteroids within the 2 months prior to screening.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helen Neighbour, MB BS PhD

Phone

905-522-1155

Ext

32145

neighbh@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen Neighbour, MB BS

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Joseph's Healthcare

City

Hamitlon

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Repeat Dose Nasal Allergen Challenge

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