NCT01110837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

April 23, 2010

Last Update Submit

October 31, 2012

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitisAllergen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Allergen

ACTIVE COMPARATOR
Other: Allergen

Placebo

PLACEBO COMPARATOR
Other: Placebo challenge

Interventions

AllergenOTHER

Allergen nasal challenge

Allergen
Placebo challengeOTHER

Placebo nasal challenge

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Healthcare

Hamitlon, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Study Officials

  • Helen Neighbour, MB BS

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Neighbour, MB BS PhD

CONTACT

905-522-1155neighbh@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 27, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

CA(1)