CClinicalTrials.gg
Status unknownNCT01110837Updated Nov 1, 2012

Repeat Dose Nasal Allergen Challenge

An interventional study of Allergen and Placebo challenge in Allergic Rhinitis, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-01.

Sponsored by McMaster University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis

Keywords

  • Allergic rhinitis
  • Allergen
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's planned enrollment of 30 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Allergen

    Other: Allergen

  • Placebo comparator
    Placebo

    Other: Placebo challenge

Interventions

  • OtherAllergen

    Allergen nasal challenge

  • OtherPlacebo challenge

    Placebo nasal challenge

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • St Joseph's Healthcare
    Hamitlon, Ontario L8N 4A6, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01110837
Lead sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
Responsible party
Sponsor
First posted
Apr 27, 2010
Start date
Apr 2010
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
Nov 1, 2012

Study contacts

Helen Neighbour, MB BS PhD
Contact
neighbh@mcmaster.ca
905-522-1155 ext. 32145
Helen Neighbour, MB BS
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion