Repeat Dose Nasal Allergen Challenge

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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other: Allergen; Other: Placebo challenge

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Neighbour, MB BS PhD; Phone Number: 32145 905-522-1155; Email: neighbh@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamitlon, Ontario, Canada, L8N 4A6
      • Recruiting
      • St Joseph's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo challenge; Placebo nasal challenge
Active Comparator: Allergen	Other: Allergen; Allergen nasal challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Helen Neighbour, MB BS, McMaster University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Allergic rhinitis; Allergen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: #09-3232