Repeat Dose Nasal Allergen Challenge

This study is currently recruiting participants.
Verified October 2012 by McMaster University
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01110837
First received: April 23, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Allergic Rhinitis
Other: Allergen
Other: Placebo challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Repeat Dose Nasal Allergen Challenge: Development of a Model to Investigate the Cellular and Inflammatory Changes That Occur in Allergic Rhinitis

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Change in peak nasal inspiratory flow following repeat allergen challenge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The peak nasal inspiratory flow will be measured using a hand-held peak flow meter, and changes will be measured following repeated allergen challenge.


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allergen Other: Allergen
Allergen nasal challenge
Placebo Comparator: Placebo Other: Placebo challenge
Placebo nasal challenge

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110837

Contacts
Contact: Helen Neighbour, MB BS PhD 905-522-1155 ext 32145 neighbh@mcmaster.ca

Locations
Canada, Ontario
St Joseph's Healthcare Recruiting
Hamitlon, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Helen Neighbour, MB BS McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01110837     History of Changes
Other Study ID Numbers: #09-3232
Study First Received: April 23, 2010
Last Updated: October 31, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Allergic rhinitis
Allergen

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014