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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03431961
Other study ID # DC002544/HIREB3820
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2018
Est. completion date February 2019

Study information

Verified date August 2018
Source Hamilton Health Sciences Corporation
Contact Gail M Gauvreau, PhD
Phone 905-525-9140
Email gauvreau@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.


Description:

Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- allergic rhinitis + mild asthma

Exclusion Criteria:

- other respiratory disease

- any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone Acetonide
220 mcg administered twice daily for 14 days
Placebo
twice daily for 14 days

Locations

Country Name City State
Canada Cardio- Respiratory Research Laboratory, Hamilton Health Sciences Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Gail Gauvreau

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cellular inflammation Nasal eosinophils 24 hours after nasal allergen challenge
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