Recruiting

Nasal Allergen Challenge

Sponsor:

McMaster University

Code:

NCT01110837

Conditions

Allergic Rhinitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allergen

Placebo challenge

Study Details

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.

Conditions

Allergic Rhinitis

Study ID

NCT01110837

Start date

Apr, 2010

Status verified date

Oct, 2012

Completion date

Apr, 2013

Anticipated

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Allergen

placebo comparator: Placebo

Interventions

Allergen

Allergen nasal challenge

Placebo challenge

Placebo nasal challenge

Primary outcome measure

  • Change in peak nasal inspiratory flow following repeat allergen challenge [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Helen Neighbour, MB BS PhD

905-522-1155neighbh@mcmaster.ca

Locations

St Joseph's Healthcare

Recruiting

Hamitlon, Ontario, Canada, L8N 4A6

More Information

Sponsor

McMaster University

Last update posted

Nov 1, 2012

Last verified

Oct, 2012

Keywords

  • Allergic rhinitis
  • Allergen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2012-11-01.